Early last month, the Union health ministry released a draft Amendment Bill, 2015 to the Drugs & Cosmetics Act for expanding its scope so as to cover new and emerging areas of the pharmaceutical industry and related sectors. The Bill, expected to be presented in the coming Budget Session of Parliament, is already placed in public domain inviting views and comments from the stakeholders including the general public. The main focus of the Bill is to effectively regulate the import, manufacture, distribution and sale of drugs, cosmetics, medical devices and conduct of clinical trials and matters connected with that. The government proposes to insert a separate chapter on clinical trials in D&C Act as there has been a lot of ambiguities in the conduct of human trials in the country for some time now. As per the proposal, no person, sponsor, CROs or investigator, shall conduct clinical trial of a new drug, new or notified category of medical device, new cosmetic, bioavailability or bioequivalence study of any new drug, in human participants except under permission granted by the Central Licensing Authority. Another key proposal is for the constitution of a Medical Devices Technical Advisory Board to advise the Central and State governments on technical matters pertaining to medical devices and to carry out other functions assigned to it.
The D&C Act of 1940 is a 75-year-old statute, framed by the British at a time when there was hardly any pharmaceutical industry in India and even the use of pharmaceuticals was limited to only some imported products. Only after India’s independence, the pharmaceutical scenario in the country underwent major changes and in a span of 50 years pharmaceutical industry emerged as one of the key industrial segments of India. During these years the pharmaceutical sector experienced several changes and challenges in the manufacturing and trade segments requiring a string of amendments to the D&C Act. Many more changes will also be required in the near future. Considering these realities, the D&C Act should have been scrapped long back and the government should have made a comprehensive new act for this vital industry instead of resorting to numerous amendments to this archaic law. Even the proposed amendment now is primarily intended to bring some clear regulatory control in the conduct of clinical trials and marketing of medical devices. In both these segments, unethical and unfair practices have been going on in the country for years with no timely and effective intervention by the government. Apart from these two segments, critical areas like pathology and diagnostics, manufacture and sale of blood products, stem cell research, etc. are still not under stringent regulatory scrutiny.