The Drugs and Cosmetics (Amendment) Bill 2013 has been 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, homeopathy and siddha) drugs for which a separate Bill will be brought in Parliament.
The nation was crying out for a new overarching authority to manage the affairs of the pharmaceutical industry in a country which was estimated to be worth $19.2 billion in 2012. Currently, the nation’s apex body behaves in an extremely disorganised – the recent pioglitazone ban being a case in point.
Drugs Hall of Shame
Here are some events from the past two years that have shown the country’s apex body for drug regulation in bad light:
Pioglitazone ban: The popular anti-diabetic ban was banned with analgin and deanxit, which drew widespread condemnation from the pharmaceutical industry. The drug was banned after one Dr V Mohan, a Chennai-based diabetologist and Chairman of Dr Mohan’s Diabetes Specialities Centre, claimed that he found eight cases of bladder cancer linked to pioglitazone use. ‘You will agree that as far as human lives are concerned, it does not matter even if only a few people develop bladder cancer and die.’ The drug was quickly banned without even consulting the Drug Technical Advisory Board. After much, hue and cry the ban was revoked.
Too many drugs being approved: ’On an average, the DCGI (Drug Controller General of India) is approving one drug every month without trials. This cannot be in public interest by any stretch of imagination,’ the panel observed. It also gave examples where the ‘opinions of experts’ were based simply on ‘personal perception’. Some of the recommendations were so blatantly one-sided that it seemed like they were written by pharma companies.
Too few qualified drug-inspectors: A parliamentary standing committee had also lashed out at the lack of quality and quantity of drug inspectors. The Parliament Standing committee said it was absolutely irrational to give a pharmacy graduate who doesn’t have any clinical or research experience the authority to approve drugs. The headquarters is staffed by four deputy DIs and five assistant drug controllers. These nine officers alone handle 20,000 applications, over 200 meetings, attend to 11,000 public/industry representatives, and respond to 700 Parliament questions and around 150 court cases annually.
Illegal tests: A PIL submitted to the SC suggested that big pharmaceuticals including GlaxoSmithKline and MSD – had tested two HPV vaccines on almost 24,000 tribal girls in Andhra Pradesh and Gujarat. The SC had also pointed out the government’s failure to halt unethical clinical trials by multinational drug companies on Indian patients who were used as ‘guinea pigs’. Referring to a May 2012 report of the Parliamentary Standing Committee on health and family welfare, judges R.M. Lodha and Anil R. Dave said ‘it really pains us that illiterate people and children of India are being used as guinea pigs by the multinational drug companies’.
Hopefully, the new bill along with setting up a powerful central body like the Central Drugs Authority, will considerably improve the nation’s $20 billion pharma industry.