THE DRUGS and COSMETICS ACT, 1940 Amendments, Clinical Trials and Consumer Protection- An Analysis.

A seminar paper submitted in the partial fulfillment of B.A LL.B (Hons.) VIIIth Semester course at Dr. Ram Manohar Lohiya National Law University, Lucknow

Submitted ToMr. Prasenjit Kundu Faculty of Health Law Submitted byTANYA VERMA B.A.LL.B. (Hons.) VIIIth Semester Roll No. - 147

TABLE OF CONTENTS

Introduction.. 03-04 Drugs and Cosmetics (Amendment) Bill, 2007 05-12 Drugs and Cosmetics (Amendment) Bill, 2008 12-17 Clinical Trials 18-22 Consumer Protection. 22-25 Conclusion. 26-28 Bibliography.. 29.

INTRODUCTION In the beginning of the current century, Drug Industry was practically non-existent in India and pharmaceuticals were being imported from abroad. The First World War changed the situation and not only were finished and cheap drugs imported in increasing volume, the demand for indigenous products also were voiced from all sides. Both Indian and Foreign manufacturing concerns sprang up to produce pharmaceuticals at cheaper rates to compete with imported products. Naturally some of these were of inferior quality and harmful for public health. The Government was, therefore, called upon to take notice of the situation and consider the matter of introducing legislation to control the manufacture, distribution and sale of drugs and medicines. Two of the laws, The Poisons Act and the Dangerous Drugs Act were passed in 1919 and 1930 respectively. But to have a comprehensive legislation, which the rapid expansion of the pharmaceutical production and drug market required by the end of the second decade for its control, the Indian Government appointed, in 1931, a Drugs Enquiry Committee under the Chairmanship Lt. Col. R. N. Chopra which was asked to make sifting enquiries into the whole matter of drug production, distribution and sale by inviting opinions and meeting concerned people. The Committee was asked to make recommendations about the ways and means of controlling the production and sale of drugs and pharmaceuticals in the interest of public health. The Committee submitted a voluminous report to government suggesting creation of drug control machinery at the centre with branches in all provinces. For an efficient and speedy working of the controlling department the committee also recommended the establishment of a well-equipped Central Drugs Laboratory with competent staff and experts in various branches for data standardization work. Under the guidance of the Central Laboratory, it was suggested, small laboratories would work, in the provinces The outbreak of the Second World War in 1939 delayed the introduction of legislation on the lines suggested by the Chopra Committee which the Indian government contemplated and considered as urgent. However, the Drugs Act was passed in 1940 partly implementing the Chopra recommendations The object of the Act is to regulate the import, manufacture, distribution and sale of drugs.

Under the provisions of this Act, the Central Government appoints the Drugs Technical Advisory Board to advise the Central Government and the State Governments on technical matters arising out of the administration of this Act. The board can constitute subcommittees for the consideration of a particular matter.

This Seminar Paper deals with major amendments and its impact on the Act including the aspect regarding Clinical Trials and also the part played by the consumers in this Act, namely, The Drugs and Cosmetics Act, 1940.

THE DRUGS and COSMETICS (Amendment) BILL, 2007

Medical drugs and pharmaceuticals are regulated by a range of laws in India with the import, manufacture, distribution and sale of drugs and cosmetics being regulated by the Drugs and Cosmetics Act, 1940. The amendment to the law attempts to increase penalties for a number of offences and sets up a regulator to licence drugs as well as set standards for drug testing. India is on the threshold of becoming the hub of clinical trials because of its high quality of research combined with low cost. The Bill strengthens the drug regulatory infrastructure in general and the laws related to clinical trials in order to prevent any kind of exploitation. The government introduced the Bill to amend the Drugs and Cosmetics Act, 1940 in order to establish a Central Drugs Authority and regulate clinical trials. Over the years, various government-appointed committees and other institutions have suggested ways to improve the drug regulatory system in the country. Some of the recommendations were incorporated in the Drug Policy, 1986 and 1994, and the Pharmaceutical Policy, 2002. In 2003, the central government constituted an expert committee under Dr. R.A. Mashelkar to review the drug regulatory infrastructure. The Committee recommended changes in drug regulation, a system of centralised licensing, enhancement of penalties, etc. A Bill, based on these recommendations, was introduced in 2003 but it lapsed due to the dissolution of Lok Sabha. The Drugs and Cosmetics (Amendment) Bill, 2007 seeks to implement some other recommendations of the Mashelkar Committee. These include establishment of the Central Drugs Authority and regulation of clinical trials.

The Drugs and Cosmetics (Amendment) Bill, 2007 seeks to replace the Drugs Technical Advisory Boards for allopathic and Indian systems of medicine with the Central Drugs Authority (CDA). Drug consultative committees may be established to advise the CDA and central and state governments.

The 2007 Bill expands the definition of drugs to include medical devices. It also defines clinical trial, states that all clinical trials require the approval of the CDA, and prescribes penalties for any person violating this provision.

KEY ISSUES AND ANALYSIS

The CDA shall be the licensing authority for the manufacture, sale or stocking of drugs and cosmetics. Currently, these functions are delegated to state governments. The 2007 Bill does not mandate medical and scientific experts in the CDA. A member can be any person with special knowledge of and a minimum of 15 years professional experience in the pharmaceutical industry, public administration, finance or law.

The Mashelkar Committee made various recommendations with regard to strengthening the drug regulatory system and the problem of adulterated and spurious drugs. Whereas several of these recommendations are being implemented through these Bills, neither Bill addresses the recommendations related to strengthening drug regulation at the state level.

KEY FEATURES OF 2007 BILL (Amendments to the Principal Act Proposed by the Drugs and Cosmetics (Amendment) Bill, 2007)

Structure for Regulation of Drugs and Cosmetics Drugs and Cosmetics Act, 1940o The central government shall establish a Drugs Technical Advisory Board and an Ayurvedic, Siddha and Unani Drugs Technical Advisory Board. o The central government may establish a Drugs Consultative Committee to advise the central and state government and the Drugs Technical Advisory Boards. The members shall be nominated by central and state governments

Drugs and Cosmetics (Amendment) Bill, 2007o The central government shall establish a Central Drugs Authority (CDA) which replaces both Drug Technical Advisory Boards. It shall consist of a Chairperson and 3 to 5 members. The CDA shall appoint a Drugs Controller (India) who shall be the Chief Executive Officer and the legal representative of the CDA. The CDA shall recommend to the central government standards for drugs and cosmetics, the Central Drugs Laboratories for testing drugs and cosmetics, measures to regulate import, export, manufacture for sale, and distribution of drugs and cosmetics, measures to regulate clinical trials etc; and may appoint Government Analysts and Inspectors. o The central government may establish a Drugs Consultative Committee and an Ayurvedic, Siddha and Unani Drugs Consultative Committee. These committees may advise the CDA as well as the central and state governments on matters related to uniformity in the administration of the law. Both Committees are to be composed of representatives of the central and state governments, industry, consumer groups, etc.

Licensing Drugs and Cosmetics Act, 1940o Central government to prescribe in the Rules the authority that would issue licenses. License for manufacture of drugs in Schedules C and C1 and imports, shall be issued by the Central License Approving Authority (Drug Controller, India). License for manufacture and sale of other drugs and manufacture of cosmetics shall be issued by Licensing Authorities appointed by state governments.

Drugs and Cosmetics (Amendment) Bill, 2007-

o The CDA will be the sole licensing authority for manufacturing for sale, export, import distribution or stocking of certain drugs and cosmetics.

Definition Drugs and Cosmetics Act, 1940o The definition of drug includes, among other items, devices intended for internal or external use in the diagnosis or treatment of disease in human beings or animals, as may be specified by the central government.

Drugs and Cosmetics (Amendment) Bill, 2007o The definition of drug expanded to include medical device, instrument, and software needed for their application, as may be specified by the central govt after consultation with the CDA. The device may be used for the purpose of diagnosis of any disease; diagnosis of or compensation for any injury or handicap or control of conception.

Creation of Fund Drugs and Cosmetics Act, 1940o No fund

Drugs and Cosmetics (Amendment) Bill, 2007o The central government shall set up a Central Drugs Authority of India Fund. It shall include all grants and fees received by the CDA. It shall be used for 8

salaries of the members and employees of the CDA and for the implementation of the Bill.

Regulation of Clinical Trials

Drugs and Cosmetics Act, 1940o Clinical trial is not defined in the Act but is detailed in the Rules. Clinical trial means a systematic study of new drugs in human subjects with the objective of determining safety and/or efficacy of the new drug. o Clinical trials shall be conducted only with the permission of the Drug Controller, (India) and an ethics committee of the testing institution. The ethics committee should have a Chairperson who is outside the institution and a mix of medical and non-medical persons. o No penalty prescribed for violating this provision.

Drugs and Cosmetics (Amendment) Bill, 2007o Clinical trial means systematic study of any drug or cosmetic [not just new drugs]. o Clinical trial can be conducted only with the permission of the CDA. o If a person contravenes this provision, he shall be punished with imprisonment for a maximum term of five years and a fine of up to Rs 10 lakh. On subsequent conviction for the same offence, the person shall be punished with imprisonment up to 10 years and a fine which may extend to Rs 20 lakh. A person can be prosecuted only on a complaint made in writing by an officer authorised by the CDA. 9

The Mashelkar Committee recommended that license for manufacture of drugs should be approved by the CDA. It cited that U.S.A., Australia, China, etc. have a centralized licensing authority. However, it did not discuss the issue of centralizing the licensing of sales and distribution of drugs. The Bill proposes to establish the CDA as the licensing authority for manufacture, import, export, sale or stocking of drugs and cosmetics. Thus, the power to issue licenses to manufacturers, distributors and retailers shall be shifted from state governments to the CDA (headquartered in Delhi). This will have cost and time implications for license applicants. The CDA may establish offices at state and district level. However, the Financial Memorandum to the Bill does not provide for funding of such offices (Clause 5F (1)). The 2007 Bill states that the central government shall appoint the Chairperson and members of the CDA with special knowledge of and at least 15 years of professional experience in the pharmaceutical industry, research or teaching, or public administration, finance or law. It is possible to constitute the CDA without any medical and scientific experts since the proportion of members from each field has not been specified. The Drugs and Cosmetics Rules of the Principal Act prescribe minimum qualifications of a Licensing Authority which include at least a graduation degree in Pharmacy or Pharmaceutical Chemistry or Medicine with specialisation in clinical pharmacology and microbiology [Clause 5(3) and Clause 5A]. The 2007 Bill was introduced in Rajya Sabha on August 21, 2007. The status of Bill is that it is still pending. The CPI (M) alleges that the Drugs and Cosmetics (Amendment) Bill-2007 is an attempt to encroach upon state governments rights, and said that the legislation provides no measures to check manufacturing and selling of spurious drugs. The party also said that its views will be put forward at the Parliamentary Standing Committee on health, which is studying the Bill at present. It also maintained that the whole purpose of the Bill is to hand over the Central Drugs Authority to MNCs and big drug companies said that the legislation provides no measures to check manufacturing and selling of spurious drugs. The party also said that its views will be put forward at the Parliamentary Standing Committee on health, which is studying the Bill at present. It also maintained that the whole purpose of the Bill is to hand over the Central Drugs Authority to MNCs and big drug companies. The Bill neither contains any clause to check 10

manufacturing and selling of spurious drugs nor there is any deterrent clause providing stronger punishment for these. The Bill only proposes central licensing. This Bill proposes to take over the drug licensing right from the state government and hand it over to the central government. If this amendment is passed by the parliament and drug licensing is centralised, thousands of small and medium sector drug manufacturing companies all over India will not be able to get their licenses and will be forced to close down; thousands of workers will lose jobs, and the self-employed will be deprived of their livelihood. Moreover the state governments will face difficulties in procurement of generic medicines and their health programmes will be seriously affected. Multinational and big companies will be monopolising the drug market. A senior leader of the CPI (M) said that the party will not allow the Bill to be passed in Parliament. At present the Bill is at the Standing Committee. Left MPs in the committee will put forward our views in the committee. The implications of the Bill are far reaching. It also raises the question on the future role of the State drug control mechanism; the licensing and control on drug distribution and sale etc. The critical area of outsourced clinical trials will be in the hands of CDA controlled and directed by drug companies. It will seriously affect national and states health programmes.

Standing committee report on DRUGS and COSMETICS (Amendment) Bill, 2007

The Standing Committee on Health and Family Welfare submitted its 30th Report on The Drugs and Cosmetics (Amendment) Bill, 2007 on October 21, 2008. The Committee feels that the physiological and therapeutic impact of drugs and cosmetics on human bodies is completely different. Therefore, trials for drugs should be separate from that of cosmetics. The Committee thus recommends that there should be a separate set of provisions for clinical trials for regulating the dermatological safety of cosmetics. The Committee also suggests that a separate definition of clinical trial for medical devices may be included in the Bill. The Committee also feels that only new drugs should be subjected to clinical trials. 11

The Committee strongly recommends that a dedicated division (as per Mashelkar Committee report) may be set up to deal with regulation, licensing, surveillance and monitoring of medical devices. The definition of medical devices should also be brought in line with the definition of Global Harmonisation Task Force.

The Mashelkar Committee had recommended that the existing Central Drugs Standard and Control Organisation (CDSCO) be strengthened and equipped properly rather than creating a new authority. The Committee, thus, recommends that the CDSCO be strengthened and restructured as a Central Drug Administration, which shall be an independent body under the Ministry of Health and Family Welfare.

The Mashelkar Committee had drawn a roadmap for centralisation of licensing in three phases. It had stated that the exercise should be complete within three years. However, the Ministry indicated that it might take five to 10 years to switch to the centralised licensing system. The Committee recommends that the roadmap drawn by the Mashelkar Committee be followed for a speedy switchover.

The Committee suggests that the appellate authority for grievance redressal should be placed in the zonal and sub-zonal offices of the licensing authority so that small scale pharma units do not face any problems.

The Committee is of the opinion that the central government would need to put substantive additional funds to strengthen the CDSCO. The Committee recommends that the Drugs Technical Advisory Board should be retained since its a technical body with representation of experts from various fields whose main function is to advise the government.

THE DRUGS and COSMETICS (Amendment) Bill, 2008 Spurious or imitation drug products are drug formulations manufactured concealing the true identity of the product and made to resemble another drug, especially some popular brand, to deceive the buyer and cash on the popularity of original product. The product may or may not contain the active ingredients. Spurious drugs are usually manufactured by unlicensed antisocial elements but sometimes licensed manufacturers may also be involved. The adulterated

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drugs are those drugs which are found to contain an adulterant/substituted product or contaminated with filth rendering it injurious to health. There were reports of availability of spurious drugs in the country which shake the confidence of indigenous as well as foreign buyers. So to make the laws relating to its manufacture and sale more stringent, The Drugs and Cosmetics (Amendment) Bill, 2008 was passed by the Parliament on 5th December, 2008. It is also known as The Spurious Drugs Bill. It provides deterrent penalties for offences relating to manufacture of spurious or adulterated drugs which have serious implications on public health. It will help regulatory authorities to handle antisocial elements involved in the manufacture of such drugs. The penalty for manufacture of spurious or adulterated drugs has been enhanced to an imprisonment for a term which shall not be less than ten years but which may extend to imprisonment for life and shall also be liable to fine which shall not be less than ten lakh rupees or three times the value of the drug confiscated, whichever is more The following amendments were brought upon by the Bill: Insertion of new section 17E which laid down the conditions when a cosmetic shall be deemed to be adulterated. Section 18 was amended i.e., clause (a) sub-clause (ii) was amended and it read any cosmetic which is not a standard quality, or is misbranded, adulterated or spurious. Amendment of Section 26A. In that section, for the word prohibit, the words regulate, restrict or prohibit shall be substituted. Insertion of new section 26B which stated the Power of the Central Government to regulate or restrict, manufacture, etc. of drug in Public interest. Amendment of Section 27. The punishment in clause (a) was amended from imprisonment not less than five years which may extend to a term of life and with fine not less than ten thousand rupees and substituted with imprisonment not less than ten years which may extend to imprisonment for life and shall also be liable to fine not less than ten lakh rupees or three times the value of drugs confiscated, whichever is more. Also a proviso and explanation to clause (a) was added which read that the fine imposed on and released from the person convicted shall be by way of compensation to the person who had used the spurious drug. If the person who had used the spurious 13

drug died due to such consumption, the compensation shall be paid to the relative of the deceased. In clause (b), the term of imprisonment for invalid licence was amended from not less than one year but may extend to three years and fine shall not be less than five thousand rupees and substituted with imprisonment not less than three years but may extend to five years and fine shall not be less than one lakh rupees or three times the value of drugs confiscated, whichever is more. In the proviso, less than one year and of fine of less than five thousand rupees was substituted with less than three years and of fine of less than one lakh rupees. In clause (c), the term of imprisonment for a spurious drug was amended from not less than three years but may extend to five years and fine not less than five thousand rupees and substituted with not less than seven years but may extend to imprisonment for life and with fine not less than three lakh rupees or three times the value of the drugs confiscated, whichever is more. Section 27A was amended. In clause (i) section 17C was substituted with section 17D or adulterated under section 17E. The amount of fine was added which shall not be less than fifty thousand rupees or three times the value of cosmetics confiscated, whichever is more. In clause (ii), the amount of fine was amended from one thousand rupees to twenty thousand rupees. Both section 28 and 28A were amended and the amount of fine from one thousand rupees was substituted with not less than twenty thousand rupees. In section 29, five hundred rupees was substituted with five thousand rupees. In section 30, subsection (1), clause (a), the words not be less than two years but which may extend to six years and with fine which shall not be less than ten thousand rupees, was substituted with not be less than seven years but which may extend to ten years and with fine-which shall not be less than two lakh rupees. In clause (b), the words, shall not be less than six years but which may extend to ten years and with fine which shall not be less than ten thousand rupees was substituted with shall not be less than ten years but which may extend to imprisonment for life and fine which shall not be less than three lakh rupees. In clause (c), the words five thousand rupees was substituted with fifty thousand rupees. In subsection (2), the words ten years, or with fine, or with both was substituted with two years, or with fine which shall not be less than ten thousand rupees or with both. 14

Section 32, sub-sections (1) and (2) were also amended. Insertion of new section 32B which dealt with compounding of certain offences. Section 33 sub-sections (2), section 33-I, sub-section (1), clause (a) and clause (b) were amended. In section 33-I, sub-section (1), clause (c) was inserted.

Section 33J was amended. In clause (a), the word two thousand rupees was substituted with fifty thousand rupees or three times the value of the drugs confiscated, or whichever is more , in clause (b), five thousand rupees was substituted with one lakh rupees or three times the value of drugs confiscated, whichever is more and in clause (c), six months and with fine which shall not be less than one thousand rupees was substituted with one year and with fine which shall not be less than twenty thousand rupees or three times the value of drugs confiscated, whichever is more.

Section 33KA which deals with disclosure of name of manufacturer, etc. and section 33KB which deals with maintenance of records and furnishing of information; were inserted.

Section 33N, subsection (2), clause (gga) amended and clause (ggb) inserted. Section 36A amended. Section 36AB, dealing with special courts, Section 36AC dealing with offences to be cognizable and non-bailable in certain cases, Section 36AD dealing with application of CPC, 1973 to proceedings before Special Court, and Section 36AE dealing with appeal and revision, was inserted.

Under the Drugs and Cosmetics Act, 1940 control over manufacture and sale of drugs is exercised by the State Licensing Authorities. Licenses for drug manufacturing establishments and sale premises are granted by the said authorities. Inspections/raids are carried out by the Drug Inspectors appointed by the States to ensure compliance of the conditions of licenses. Samples are drawn by Drug Inspectors to check the quality of drugs marketed in the country. Legal/administrative actions as required under the said Act and Rules for the violation of the 15

provisions of the Act are taken by the State Licensing Authorities. There are certain guidelines under the new provisions. While implementing the new provisions, the State Regulatory Authorities should ensure that the law is implemented in a comprehensive way. In order to effectively use the said instrument of law, it is necessary to have Standard Operative Procedures set in each State to examine and process various violations of the provision of the Act. The State Drug Control Organizations should have internal mechanism of checks and balances to ensure that law abiding manufacturers and sellers of drugs are not harassed or put to a disadvantageous position. Care should be taken that while violations with criminal intent or gross negligence leading to serious defects are dealt with heavy hand, the violations involving minor variations in quality by licensed manufacturers are resolved through administrative measures.

Principle for Institution of Prosecution under Drugs and Cosmetics Act: The weapon for prosecution should be used sparingly and judiciously but due regard to merits of the case be given as a prudent measure. Prosecution should be launched where administrative measures have failed to have desired effects. However, while deciding to prosecute, due regard should be given to the nature of contraventions. The persistent defaulter should be prosecuted but minor omissions may not form the basis of prosecution. Administrative action should be initiated wherever possible to ensure preventive measures to safeguard public health. A broad classification of cases where prosecutions should be launched is given below: 1. Where a spurious drug of drug falling within the meaning of adulterated/spurious/misbranded under Section 17(A), 17(B) and 17 of Drugs and Cosmetics Act is manufactured, sold or stocked or exhibited for sale or is distributed. 2. Cosmetic falling within the meaning of spurious cosmetics under Section 17(D) and misbranded under Section 17(C). 3. Where drugs/Cosmetics are manufactured without a licence. 4. Where a parenteral preparation is reported by the Government Analyst to be nonsterile, pyrogenci or toxic and provided on investigation is found to be substandard due 16

to lack of adequate quality control and adherence to the provisions of GMP in the manufacturing processes. 5. Where a drug is found grossly sub-standard repeatedly.

Initiative taken by the Government to Enforce Drugs and Cosmetics Act More Effectively i. Whistle blower scheme Whistle Blower Scheme has been announced by Government of India to encourage vigilant public participation in the detection of movement of spurious drugs in the country. Under this policy the informers would be suitably rewarded for providing concrete information in respect of movement of spurious drugs to the regulatory authorities. ii. Guidelines for taking action on test reports in the light of enhanced penalties In the 40th meeting of Drugs Consultative Committee (DCC) consisting of the DCGI and all State Drug Controllers held on 29.6.2009, guidelines for taking action on samples of drugs declared spurious or not of standard quality in the light of enhanced penalties under the Drugs & Cosmetics (Amendment) Act, 2008 were adopted for the purpose of uniform implementation of the Drugs and Cosmetic Act in the country. The guidelines with approval of the Ministry of Health were forwarded to the State Drugs Controllers for information and compliance iii. Strengthening of drug testing laboratories Under a Capacity Building Project through World Bank, assistance was provided to upgrade testing facilities and to establish new drug testing laboratories in the country so as to enhance the capacity of the laboratories to test large number of samples. iv. Good manufacturing practices Schedule M to the Drugs and Cosmetics Rules, 1945, pertaining to Good Manufacturing Practices was amended to make it at par with the international standards and it is mandatory for the manufacturers of drugs to comply with the requirements of this Schedule for quality control of the drugs manufactured by them. 17

v. Other Measures a) To take care of the quality of import/export consignments of drugs which are presently kept along with food stuff, meat and other general cargo, it has been decided to set up exclusive pharmaceutical zones with dedicated area for storage of drugs meant for export/import at Delhi, Hyderabad and Mumbai Airport.' CDSCO is involved in negotiation/consultation with the port authorities in the matter. b) To take care of increased traffic of import and export of drugs, two Sub-Zonal offices at Hyderabad and Ahmadabad airport have been converted into Zonal offices. A new SubZonal office at Bangalore airport has also been set up to cope up the situation of increased traffic of import and export of drugs in that region. It has also been decided to set up a sub zonal office at Chandigarh as northern India has become a major Pharma hub due to setting up of large no. of drug manufacturing units in the excise free zones. c) Detailed guidelines have been issued to the State Govts. To undertake focused surveillance over possible movement of spurious drugs. d) Training programme for regulatory officials of State Govts. On logistics of intelligence, surveillance, prosecutions, etc. has been conducted with the assistance of FDA, Maharashtra. e) Pharma industry and traders has been motivated to fight menace of spurious drugs as a shared responsibility. No. Of cases could be successfully detected through the initiative taken by Pharma industry involving hiring of retired intelligence officers.

CLINICAL TRIALS

Clinical research is the key to the discovery of latest diagnostic methods and to develop modern drugs for treatment of diseases. Drug development is a process that calls for utmost 18

care. An error can cause fatal result. Clinical trials are developed in such a way that it not only helps the discovery of new drugs but also ensures safety profile of such drugs. A clinical trial in simple terms can be defined as a set of practice that helps certify a new drug molecule as safe and efficacious before reaching the market. In fact "any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes" can be defined as a clinical trial. To determine the safety and efficacy of drug research on humans is always warranted, but one needs to be cautious and vigilant about the process. Adherence to the principles of good clinical practices or GCPs, including adequate human subject protection universally recognized as a critical requirement to the conduct of research involving human subjects. Most countries have adopted good clinical practice principles as laws or regulations. In India, compliance with GCP guidelines issued by the Central Drugs Standard Control Organization or the CDSCO is recommended. It has been widely recognized that India offers unique opportunities for conducting clinical trials in view of the large patient pool, well- trained and enthusiastic investigators and premiere medical institutes available in the country along with considerable low per patient trial cost, as compared to developed countries. A need was, however, felt to develop our own Indian Guidelines to ensure uniform quality of clinical research throughout the country and to generate data for registration for new drugs before use in the Indian population. In India, regulations pertaining to clinical trials are placed in Schedule "Y" of the Drugs and Cosmetics Act 1940, and the rules framed thereunder. It deals with regulations relating to clinical trial requirements for the import, manufacture and obtaining marketing approval for a new drug in India. Earlier, it required that all foreign drugs be retested at one phase below the highest phase of testing abroad. But, after the 2005 amendment to the Schedule Y of the Act, parallel global clinical trials are possible and India now permits concomitant phase 2 and phase 3 trials. New chemical entities cannot be administered to human subjects in a clinical trial without permission from the Drugs Controller General of India. Such permission may be obtained by 19

submitting to the DCGI an application for a clinical trial. The application must include a protocol for the study, a draft of the Informed Consent Document, a list of proposed investigators who have agreed to participate in the study, and background information about the drug in accordance with Schedule Y of the Drugs & Cosmetics Rules. It takes almost 12 weeks to obtain permission for a clinical trial for most investigatory drugs. The duration may be longer for drugs with special significance to the healthcare concerns of the country or those that may be considered controversial since these are liable to be referred to the Indian Council of Medical Research for comments. If clinical supplies are to be imported, a "Test-Import License" must also be applied for. Import and manufacture of clinical trial supplies is governed by Rules 33 & 34 and provisions contained in Part X-A of the rules.

Regulation of Trials

In conducting research, informed consent is the most basic and complex principle of clinical research ethics. An ethically valid informed consent has four key components: disclosure, understanding, voluntariness, and competence. In that case, the usual question that arises is whether the concept of informed consent extends to research involving the critically ill, because in many cases, critically ill patients are incompetent or unable to make a sound decision. Sometimes, the family members may not know the patient's wishes, or may not be legally authorized to give consent for the patient's involvement in research. All such issues create challenges for researchers in pediatrics, psychiatry, emergency and critical care medicine. The Drugs Controller General of India or the DCGI is responsible for regulatory approvals of clinical trials in India. The DCGI's office depends on external experts and other government agencies for advice. The ICMR has a Central Ethics Committee on Human Research. This committee audits the functioning of this Institutional Ethics Committee or the IEC. The recently amended Schedule Y of Drugs and Cosmetic Rules order the composition of the IEC as per the ICMR guidelines.

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Compliance with GCP guidelines issued by the Central Drugs Standard Control Organization or the CDSCO is recommended although this does not have statutory status at the present time. A report on the status of the study with details of enrolment and safety issues also needs to be submitted annually and on completion of every study. These measures suggest that India do have guidelines and regulations at par with the international standards; but, the insufficiency lies with regard to the implementation of these control mechanisms. The shortfall is mainly due to the lack of sanction attached to such provisions in case of violations. The regulatory mechanisms available in the country are scattered in various guidelines having less or sometimes no force of sanction. Shocking Violation of Human Rights

Informed consent is an essential requirement of medical trials, which denotes that the patient undergoing treatment as part of the study should be made aware of the trial being conducted, the drugs being administered on him and its possible side effects. In 1999, without obtaining consent of the patients who were under treatment in the government-run Regional Cancer Centre in Trivandrum, an experimental drug tetraglycinyl nor-dihydro-guaiaretic acid was administered on them. Though there was an established treatment for their condition, they were not informed that they were taking part in an experiment or that they were being denied an established treatment. In 2003, Mumbai-based Sun Pharmaceutical Industries Ltd. launched a promotional-cumresearch programme by getting private doctors to prescribe the anti-cancer drug Letrozole to more than 400 women as a fertility drug for ovulation induction. The company then publicized the doctors' reports to other doctors as "research", using their network of medical representatives. The drug was prescribed despite the fact that it was known to be toxic to embryos. In 2010, government and private doctors in Indore, Madhya Pradesh, reportedly carried out clinical trials of various medicines on around 233 patients who went to them seeking psychiatric treatment. The trials, to test medicines produced by pharmaceutical companies, were conducted between January, 2008 and October, 2010 without following proper 21

guidelines. Following a huge media uproar, 12 Doctors including six involved in the trials on mentally ill patients were fined just Rs. 5,000 each for not informing the parent hospital about the conduct of trials and for ignoring protocols. The matter pertaining to the drug trials on mental patients in contravention of Schedule Y of the Drugs and Cosmetics Act, which has explicit guidelines for clinical trials involving the mentally ill, and the Indian Council of Medical Research's (ICMR) Ethical Guidelines for Biomedical Research on Human Participants, was raised by a former resident doctor of MGM Memorial Medical College in January 2011 who wrote to the NHRC, which in turn referred his complaint to the State Human Rights Commission. In the third week of November 2011, the Union Ministry of Health and Family Welfare proposed amendments to the Drugs and Cosmetics Rules, 1945, relating to regulations in clinical trials. The amendments had been approved by the Drug Technical Advisory Board, a statutory committee under the Drugs and Cosmetics Act, 1940. The notification dated November 18, 2011, pertaining to the draft rules called the Drugs and Cosmetics (3rd Amendment) Rules, 2011, seeks to strengthen the regulations in favour of trial subjects but has many loopholes. Moreover, it was not given adequate publicity to elicit responses. The draft rules claim to have incorporated effective provisions to provide financial compensation to trial subjects in case of trial-related injury or death; enhance the responsibilities of the ethics committees, the sponsor and the investigator to ensure financial compensation and medical care to trial subjects who suffer injury or death; and amend the format for obtaining consent to include details such as address and occupation, and annual income of the subject so as to have information of the socio-economic status of the trial subjects. Barring certain weak and cosmetic changes to the Drugs and Cosmetics Rules, relating to compensation in case of injuries to and death of trial subjects, no measures have been taken to strengthen the system in favour of those undergoing trials. Notwithstanding the Ethical Guidelines for Biomedical Research on Human Participants framed by the ICMR in 2006, norms continue to be flouted by both the public and private sectors in health care. The framework to deal with issues of compensation, consent and

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transparency is considered very weak, leading to several allegations, many of which seem to be well-founded, of exploitation of the poorer sections. These are only a few of the numerous shocking human rights violations that have been exposed in the area of clinical trials. These instances throws light on the lacunae in the Indian legal system for penalizing drug companies that violate norms and mess up while conducting global clinical trials.

CONSUMER PROTECTION

We can trace the Indian tradition of protecting consumer interest from its historical past. We can find the references of consumer protection against exploitation by the trade and industry, short weighment and measures, adulteration and punishment for these offences in Kautilyas Arthashastra20. Prior to independence, the main laws under which the consumer interests were considered were the Indian Penal Code, Agriculture Production, Grading and Marketing Act, 1937, Drugs and Cosmetics Act, 1940. In order to defend the cause of consumer in the area of drugs and cosmetic industries in India, Drugs and cosmetic act of 1940 was enacted so as to regulate the airport, distribution and sale of drugs. In pursuance to the recommendations the pharmaceutical enquiry committee appointed by the Government of India, the drugs and cosmetics act, 1940 empowers the central government to control the manufacture of drugs, to appoint inspectors for inspecting manufacturing premises and taking samples of drugs, to appoint government analysts to whom samples drawn by such inspectors could be sent for analysis and to issue the state government for carrying into any of the provisions of the Act.

The contemporary era is marked as the era of consumers. No country can knowingly or unknowingly disregard the interest of the consumers. This can be argued on the basis of fast enactment of consumer protection laws in almost all part of the world.

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Cosmetics are substances which are defined under the Drugs and Cosmetics Act 1940 and Rules 1945 as Articles which are meant to be rubbed, poured, sprinkled, or sprayed on or introduced into or otherwise applied to the human body for the purpose of cleansing, beautifying, promoting attractiveness or altering the appearance. Cosmetics are luxury articles and for the past few years, usage of cosmetics has increased multifold, resulting into an increased production, import, distribution and sale of cosmetics. These items may contain some ingredients, the constant use of which might prove to be harmful and hence needs control. The safety of cosmetic products is of prime importance for the general consumers. The Drugs and Cosmetics Act 1940 is a Consumer Protection Legislation which is mainly concerned with the standards and quality of drugs and cosmetics manufactured and sold in India.

The cosmetic products have to be formulated and manufactured in accordance with Schedule M-II of Drugs and Cosmetics Act 1940 and Rules 1945.

Cosmetic products are now considered no less than pharmaceutical products (medicines) in terms of ingredient selection and its quality control. They are also required to follow good manufacturing practices. Validation of processes and equipments, labeling requirement, shelflife testing, animal testing, etc. are now an essential part of cosmetic manufacturing. Certification from standards regulating bodies like BIS (Bureau of Indian Standards) and ISO (International Organization of Standards) adds to the reputation of the cosmetic manufacturing company. Sale of Cosmetics in India Cosmetics are exempted from any sales licence, provided that the cosmetics, if of Indian origin, are manufactured by the licensed manufacturers. But there is a prohibition on the manufacture and sale of certain cosmetics, viz. i) Any cosmetic, which is not of a standard quality or is misbranded or spurious, or

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ii) Any cosmetic containing any ingredient which may render it unsafe or harmful for use, viz, containing hexachlorophene, mercury, lead or arsenic compounds as colourants or those containing colours other than prescribed. iii) Manufacture and sale of cosmetics is also prohibited unless those have been manufactured in accordance with the condition of a licence issued for the purpose or have been imported in contravention of any legal provision.

Manufacture of Cosmetics A person licensed to manufacture cosmetics should comply with the following conditions, as specified in schedule M-II of the Drugs and Cosmetics Act 1940 and Rules 1945. The factory premises should be situated in hygienic surroundings and kept clean and should be distinct and separate from premises used for residential purposes. The license should possess adequate space, building and equipment for the manufacturing process.

As per the conditions of the license, any change in the technical staff should be reported to the licensing authority. The Drugs and Cosmetics Act 1940 is a punitive Act. Anybody manufacturing cosmetics in contravention of the Act and the Rules is punishable with imprisonment upto one year or fine upto Rupees 1000/- or with both on first conviction and for the manufacture of spurious cosmetics, imprisonment upto three years and with fine. The penalty for subsequent offences in both the case is imprisonment upto 2 years or fine upto Rupees 2000/- or with both (subject to revisions or amendments).

Cosmetics and Consumers Out of the 28 cosmetics that are listed in Schedule S of the Drugs and Cosmetic Rules 1945, they can be categorized widely as Commonly used cosmetics: Toothpowders, Toothpastes, Hair Oils, Cold creams, Henna, Depilatories, Shampoos, and Hair Dyes. Cosmetics used by men: Shaving creams, after shave lotions, Colognes, Hair creams, Brilliantines. 25

 Cosmetics used by women: Lipsticks, Face powder, Nail lacquer, Bindi. Children are also consumers of cosmetics, for example, Baby oil, Baby shampoos, Baby creams, Baby lotions, etc. Recent media reports about a consumer complaint to Maharashtra FDA against Johnson and Johnsons Baby Oil has adequately attracted the public attention to the safety issues of cosmetics used in this country. Complaints from consumers, like in the Johnson and Johnson case, bring to fore that there is certainly a need to look at the adequacy of existing rules on cosmetics and their proper implementation. Since there is not system of granting premarket approval for cosmetics in India, as it is done in case of medicines, companies producing cosmetics and toiletry preparations are marketing them without any toxicity studies and clinical trials.

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CONCLUSION

The Drugs and Cosmetics (Amendment) Bill, 2007 has not been passed yet. It was introduced in the Rajya Sabha on 21st August, 2007. The Drugs and Cosmetics (Amendment) Bill, 2008 has been passes by the Parliament.

There is ambiguity in the amended Drugs and Cosmetics Act over the definition of the terms adulterated and spurious drugs could affect Indian generic drug players. The amendment could complicate both patent challenges as well as regulation of companies, according to industry observers. The amended law has provided for stricter punishment for companies charged with manufacturing adulterated or spurious drugs. Under the new law, evidence of both adulteration and manufacture of spurious drugs needs to be established for a person to be convicted. However, there is still some ambiguity in the Act, which needs to be addressed immediately. Although the increase in penalties for dealing in spurious drugs may be welcome, the fact that the definition of spurious remains substantially the same is a grave 27

cause for concern. This definition could be interpreted to even catch within its fold legitimately-authorised generics of good quality and this is problematic. Loopholes in the law have been noticed both by intellectual property lawyers and companies alike. This was evident in the recent Bayer-Cipla case. Bayer, in the recent drug patent linkage case, suggested that Ciplas generic version of Nexavar would qualify as spurious. Given that the government is fighting international efforts such as IMPACT which attempt to define counterfeiting broadly to even catch legitimate generics, the government must, as a first step, clean up its own backyard by redefining spurious. It must ensure that the term spurious as used within the context of drug regulation be simply restricted to substandard drugs. IP issues should not form part of this definition. And in any case, barring straightforward violations of identical trademarks, the DCGI often does not have the institutional competence to decide complex trademark disputes. Another point in the law that is of concern is the non-binding power that it gives authorities. The purpose of the amendment is to curb the spread of adulterated drugs and that is a welcome move. But the powers given to authorities like the state Food and Drug Administration are non-binding on them and there are concerns that these may be misused. With the lack of clarity on the definition of adulterated and spurious, large companies are more likely to use this as a way to block generic companies from challenging their patents and manufacturing generics. This could harm the generic industry as a whole and if it is not sorted out soon.

With an exponentially growing clinical trial market, India promises to be one of the major destinations for global clinical trials. But, at the same time, to rely simply on minimum standards of non-binding and vague medical ethics is both naive and culturally insensitive. To address the challenges and key issues, India should devise policies and ensure implementation in legislative, Intellectual Property Rights structure and regulatory issues. As per an amendment proposed by the Drug Controller General of India (DCGI) in the Drugs and Cosmetics Rules, failure to provide compensation for injuries related to the clinic trial, or to the heir in case of death, may lead to suspension or cancellation of the trial. Foreign sponsors may not be allowed to conduct trials in India if they fail to pay compensation. There is also a need to develop Clinical Research Organizations with adequate capacity and competency in carrying out research activities in compliance with ICH/GCP guidelines. What are required are speedy implementation and, necessary investment and infrastructure 28

support. India should realize the fact that laws alone would not suffice; there should be a proper administrative and monitory mechanism to ensure its working. Lack of regulatory jurisdiction over private trial sites and absence of uniform application of the need for informed consent and proper ethics review have raised concerns about trials conducted in India. What is needed is to establish authorities such as the proposed Central Drug Authority and central licensing mechanism for manufacturing approvals. This would essentially help keep a check over the activities of firms conducting drug trials in India.

Lastly, The Drugs and Cosmetic Act 1940 is a pre-independence legislation and is expected to regulate two highly profit making industries in India that is the medicines and cosmetics. As substandard medicines are life threatening, drug regulatory bodies, maintain more strict vigil and monitoring is routinely exercised. Unfortunately, cosmetic regulations are not very strictly followed. But it should not be forgotten that use of a spurious or irrationally produced cosmetic product could also seriously harm different parts of the human body. It is quite possible that there could be numerous cases of harmful effects of cosmetics going unreported to authorities. There is a strong requirement for implementation and enforcement of provisions of Drugs and Cosmetic Act 1940 and Rules 1945 in the country which will cover the sale, manufacture, import and labeling of cosmetics. In order to have reasonable safety for cosmetic products, it is also now realized that certain new standards should be laid down to test for the safety of ingredients added in cosmetic products, specially, baby cosmetics.

In the present socio economic scenario we find that the consumer is a victim of many unfair and unethical tactics adopted in the market place. The untrained consumer is no match for the businessman marketing goods and services on an organized basis and by trained professionals. He is very often cheated in the quality, quantity and price of the goods or services. In recent years, there has been a greater public concern over the consumer protection issues all over the world. Taking into account the interest and needs of the consumers in all countries, particularly those in developing countries, the consumer protection measures should essentially be concerned with (i) the protection from hazards to health and safety; (ii) the promotion and protection of economic interests; (iii) access to adequate information; (iv) control on

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misleading advertisements and deceptive representation; (v) consumer education and (vi) effective consumer redress.

Therefore, the Drugs and Cosmetics Act, 1940 is an Act to regulate the import, manufacture, distribution and sale of Drugs and Cosmetics. Though it has been subjected to a lot of amendments, it is still not flawless. There are loopholes in the Act which are to be covered but it has still made the laws relating sale and manufacture of drugs strict enough to encompass in its scope any violation made by the sellers and the manufacturers but it still has to incorporate laws regarding liability of doctors in unethical trials and make laws regarding consumer protection more rigid.

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BIBLIOGRAPHY

Books

Vijay Malik, Laws Relating to Drugs and Cosmetics, 22nd Edn.

Websites www.prsindia.org www.legalserviceindia.com www.majumdarindia.com www.consumereducation.in www.medindia.net www.kppub.com www.ssrn.com www.lawyersclubindia.com www.rajswasthya.nic.in www.cdsco.nic.in www.indiaoppi.com www.post.jagran.com www.scribd.com www.articlesofadvocate.blogspot.in

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