The Drugs and Cosmetics (Amendment) Bill, 2013 also aims to include creating a separate chapter of the clinical trials sector, which will introduce strict penal provisions for the payment of compensation, registration and the creation of ethics committees.
The bill will replace the 1940 Drugs and Cosmetics Act, whereby this 19-member overarching Authority will regulate the cosmetics sector in India, which will be headed by the secretary, of health and family welfare.
A previous attempt was made to introduce the idea in Parliament six years ago, but was defeated.
New Bill successfully passed through parliament
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 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 excludes all provisions relating to Ayush drugs for which a separate bill will be brought in Parliament.
The proposed body will be headed by the health secretary and include secretaries of seven related ministries as members, as well as nominees and experts in the field and the Central Drug Authority would have the power to review licenses granted to cosmetics and suspend or cancel those which did not meet requirement.
Cutting through the tangle
The Indian parliament is interested in creating a centralized licensing body in part because of a need to centralize the manufacture, sale and distribution of drugs.
Currently, the system has a cumbersome method by which a new drug is approved for marketing by the Central Drugs Standard Control Organization (CDSCO) but a license for its distribution needs to be issued by individual states.
The tangle is made worse by the fact that many states do not have officials with the necessary skills to evaluate a drug or cosmetic product before issuing a license.