The draft guidelines of the proposed new Bill released by the Department of Health and Family Welfare, proposes to insert a separate chapter on clinical trial, Chapter 4A in it. The Bill is expected to be placed before the Parliament for its approval during the Budget session.

"Any new drug or investigational new drug in contravention of section 4A and the rules made thereunder, shall be punishable with imprisonment which may extend to three years or fine which may extend to five lakh rupees or both. Whoever, having been convicted under section 4K, is again convicted under that section, shall be punishable with imprisonment for a term which shall not be less than three years but which may extend to five years and shall also be liable to fine which shall not be less than Rs 15 lakh," the guidelines said.

The Drugs Control Officer or any other officer authorised by the Central Licensing Authority shall have the power to enter with or without prior notice into any premises related to clinical trial to inspect the facilities, record, data, documents, books, drugs including investigational new drugs,
notified category of medical devices and cosmetics, it further said.

The new Bill also empowers the Central Government to suspend or cancel any permission, licence or certificate issued by the Central Licensing Authority or a State Licensing Authority, in public interest among other reasons.      

The proposed Bill also says that any company manufacturing cosmetic which is found to be adulterated or spurious would be punishable with imprisonment up to five years, besides fine not less than Rs two lakh or three times value of the cosmetics confiscated, whichever is more.

Latest News from India News Desk