According to the revised version of a bill that has been sent for inter-ministerial consultations, the Center has suggested that the Central Drugs Standard Control Organization (CDSCO) should be given the authority to regulate the manufacture of drugs or cosmetics rather than the state drug regulators, as is the current practice.

The New Pharmaceuticals, Medical Devices, and Cosmetics Bill, 2023, which is proposed to replace the current Drugs and Cosmetics Act of 1940, stated that the sale of drugs, cosmetics, and medical devices will still be subject to state regulation. The new draft, titled "The New Drugs, Medical Devices, and Cosmetics Bill," was made public in July 2022 to seek feedback from the stakeholders.

The ministry stated that they received multiple comments on the new bill. They added that the ministry has made the necessary revisions and forwarded the measure for inter-ministerial consultations.

Additionally, the governments think tank, NITI Aayog, supported the recently introduced provision that will allow the CDSCO to issue manufacturing licenses for drugs and cosmetics instead of the state regulators. They reasoned that this would ensure uniform and effective application of the law and represent a significant shift towards placing all manufacturing responsibilities with a central licensing authority.

A license issued by the central licensing authority in the form and manner that may be regulated must be followed in order to manufacture any medication or cosmetic for sale or distribution, according to Section 22(c) of the draft proposal. Presently, all manufacturing activities related to drugs and cosmetics are regulated by the respective state governments through their drug control organizations. However, once the proposed bill is passed by Parliament, all the powers of the state governments related to the manufacture of drugs and cosmetics will be held by the Center through the CDSCO.

Furthermore, an official stated that the new bill includes a number of definitions or provisions, including those for bioequivalence study, bioavailability study, clinical trial, clinical investigation, controlling authority, manufacturer, medical device, new drugs, over-the-counter (OTC) drugs, adulterated cosmetics, etc., for smoother operation and implementation.

(Source: https://health.economictimes.indiatimes.com/news/policy/centre-should-regulate-manufacturing-of-drugs-instead-of-state-bodies-new-bill-moots/98584369 )