Written By: Nirmalya Dutta | Published : February 6, 2014 10:06 AM IST
Health Minister Ghulam Nabi Azad said on Wednesday that the central government was contemplating relaxing norms for clinical trials in India. 'There has been more than 50% drop in clinical trials after stringent regulations were put in place last year. We did it to improve transparency, but that should not happen at the cost of innovation. Industry feels that regulations we have made are too difficult. I think we need to strike a balance, considering the rise in some deadly diseases,' he said at an event held in biopharma company Biocon's facility.
Only last year, the Union Health Ministry made sweeping changes to the Drugs and Cosmetics Act, 1940, following a Supreme Court order. The act made it mandatory or the principal investigator of the pharma company to reveal the contract between the subject and the company to the DCGI and companies also had to video record the consent given by volunteers. It also laid down tough rules to make companies liable for any serious adverse events (SAE) which occurred to the drug trial subject. Read the shocking tales of illegal clinical trials on tribal girls.
Kiram Mazumdar Shaw, Chairman and Managing Director of Biocon however, pointed out that India's reticence for trials were forcing companies to seek greener pasturers. 'The less than conducive environment for clinical trials in India is forcing researchers to take their studies to other global regions outside India, resulting in a setback to Indian patients.'
What is the Drugs and Cosmetics (Amendment) Bill 2013?
The Drugs and Cosmetics (Amendment) Bill 2013 was introduced in Rajya Sabha with an aim of strengthening the drug regulatory system in India and provides the scope for setting up of a Central Drugs Authority as an overarching body for regulation of drugs and cosmetics. It seeks to establish a 19-member overarching body to regulate the drugs and cosmetics sector that will be headed by the Secretary, Health and Family Welfare. The amended bill is a comprehensive legislation to cover various aspects of drugs and cosmetics including regulation of clinical trials and the medical equipment sector, having separate chapters on clinical trials and medical devices. The bill that seeks to replace the Drugs and Cosmetics Act, 1940, was introduced in the Rajya Sabha by Health and Family Welfare Minister Ghulam Nabi Azad said who also withdrew the Drugs and Cosmetics (Amendment) Bill, 2007.
The CDA will specify regulations and norms for effective functioning of central and state drug licencing authorities and will periodically assess their functioning. It can also review, suspend or cancel any permission or licence for drugs and cosmetics manufacturing. The new Bill also proposed centralised licencing in respect of 17 categories of very critical drugs. The Bill also contains a separate Chapter for regulatory provisions for medical devices and for regulating clinical trials and exports of drugs and cosmetics. While no person can conduct any clinical trial for a new drug or medical device or cosmetic, the Bill contains severe penal provisions for its violations that include imprisonment of maximum 10 years and penalty of up to Rs 30 lakh. The new bill excludes all provisions relating to AYUSH (Ayurveda, yoga, unani, homoeopathy and siddha) drugs for which a separate Bill will be brought in Parliament.
The Clinical Trial issue
2013 started with the shocking news that a US-based NGO called PATH (Programme for Appropriate Technology) tested cervical cancer vaccines on tribal girls, illegally. The subsequent petition filed in the Supreme Court named various renowned companies including Glaxo Smithkline and MSD Pharmaceuticals, and alleged that they had tested two unproven HPV vaccines gardasil and cervarix on almost 24,000 tribal girls in Andhra Pradesh and Gujarat, including 44 people at the Maharaja Yeshwantrao Hospital (MYH). Of these 44, ten were males! The trials were eventually suspended, following the deaths of five girls in Andhra Pradesh, and two deaths in Gujarat in 2009-10 after being administered the said HPV vaccines.
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