Drug trial regulation: The changing scenario in India

By Rachna Bharadwaj, Krishna & Saurastri Associates
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The Indian drug trial industry has witnessed regulatory challenges in the area of clinical trials, new drug pricing policy, compulsory licences and foreign direct investment cap for brownfield projects in the past year. A public interest litigation pending in the Supreme Court coupled with regulatory uncertainties has halted clinical trials in India.

However amid the uncertainties and delays, there have also been developments that are likely to bring impetus to the drug trial industry, which was estimated to be worth US$19.2 billion in 2012. These include: (1) the recommendations of an expert committee report on clinical trials, new drug approval and banning of drugs; (2) the Drugs and Cosmetics (Amendment) Bill, 2013; and (3) a web-based petition to the Supreme Court by People for the Advancement of Clinical Research – India.

Rachna Bharadwaj
Rachna Bharadwaj

Clinical trials

Clinical trials are an essential component of drug discovery. In order to generate adequate evidence to establish safety and efficacy of a substance for any specific indication, it is necessary that in addition to all in vitro, in vivo, and ex vivo experimentation, the product is administered to healthy volunteers and patients and clinically studied under a well defined protocol.

India’s provisions for regulating and ensuring quality, safety and efficacy of drugs are contained in the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945. The regulatory provisions for conducting clinical trials are prescribed under rules 122DA, 122DAA, 122 DAB, 122DAC, 122DD, 122E and Schedule Y of the 1945 rules. Clinical trials can be initiated only after approval by the Drugs Controller General of India and clinical trial registration with the Clinical Trials Registry – India.

Government initiatives

In order to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs, the Ministry of Health and Family Welfare (MOHFW) constituted an expert committee under the chairmanship of Professor Ranjit Roy Choudhary. The actions proposed to be taken on the committee’s recommendations, as finalized by the MOHFW, include: (1) accreditation of investigators, clinical trial sites and ethics committees; (2) procedure for review of applications for clinical trials and new drugs; (3) computerized database and selection of experts; (4) specific timeline for processing of applications; (5) audio/video recording of informed consent; (6) use of information technology at all steps of a clinical trial to ensure total transparency; (7) waiver of clinical trials involving an Indian population for approval of new drugs already approved outside India in cases of national emergencies, epidemics and for drugs for rare diseases; and (8) increasing the duration of post marketing surveillance from four to six years.

The MOHFW proposes to strengthen and upgrade the Central Drugs Standard Control Organization (CDSCO) by increasing its manpower to 1,102 posts at different levels during the 12th Five Year Plan (2012-17), and to create a Research Unit within the CDSCO. The unit would initiate and sponsor studies to obtain information needed to help in making decisions to remove hazardous drugs and drugs that lack a rational foundation from the market.

Comprehensive bill

Further, the Drugs and Cosmetics (Amendment) Bill, introduced in the Rajya Sabha on 29 August 2013, contains specific provisions for regulating the conduct of trials and penal provisions which are conspicuously absent from the 1940 act. Conducting a clinical trial of any drug or investigational drug or any medical device or investigational medical device without permission would invite a penalty up to ₹3 million (US$48,500) and a maximum of 10 years’ imprisonment.

The bill contains separate chapters on medical device and drug trial regulation, as well as on exports of drugs and cosmetics, and covers various other aspects of drugs and cosmetics. It sets norms for the effective functioning and assessment of central and state drug licensing authorities. Any permission or licence for drugs or cosmetics manufacturing will be subject to review, suspension or cancellation. The bill also provides for centralized licensing in respect of 17 categories of very critical drugs.

What next?

The parliamentary standing committee on health and family welfare is examining the bill and is likely to submit its report soon. The panel is expected to consult interested stakeholders, including the public, by taking oral evidence and inviting written memorandums containing suggestions, views and comments from individuals, institutions and organizations interested in the subject matter of the bill for wider consultation.

The greatest challenge is to restore the clinical trial industry in India as soon as possible, ensuring access to new drugs that have been tested using the most stringent regulatory standards.

Dr Rachna Bharadwaj is an associate at Krishna & Saurastri Associates and an advocate registered with the Bar Council of India.

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