[Answered] The New Drugs, Medical Devices, and Cosmetics Bill needs to be revised to create an efficient system of drugs regulation in India. Discuss

The Union Health Ministry recently published a new draft Bill to replace the outdated Drugs and Cosmetics Act, 1940 which regulates the import, manufacture and distribution of drugs in India. The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards.

Issues:

• The new bill does not provide for the enforcement of provisions of good manufacturing practices (GMP).
• The previous law did not contain any criminal penalties for pharmaceutical companies failing to comply with GMPs. The new Bill does nothing to change this system.
• Uneven enforcement of the Drugs and Cosmetics Act across India because India has 37 agencies along with the Central Drugs Standard Control Organisation (CDSCO), for enforcing drug regulation across the country. The bill does not address the need for a single regulator.
• The new law does not address the critical issue of transparency in the approval process of drugs.
• The proposed legislation does not make accommodations for public participation.
• Modern regulation delegates an incredible amount of power to unelected bureaucrats and technocrats. From the perspective of accountability, it leads to a democratic deficit.

What should be done?

• Mashelkar Committee in 2003 had recommended centralizing drug licensing with the central regulator.
• The law should guarantee proactive disclosure of all crucial documentation related to regulatory decisions on the approval or rejection of drugs. If a new drug is being approved, the regulator should be required to disclose all the data, including clinical trial data.
• Each inspection for GMP compliance should conclude with an inspection report accessible to the general public to ensure accountability and build public confidence in the regulator.
• A modern regulatory system should be designed in a manner that guarantees citizens a right to participate in decision making.
• Create legal pathways, such as public hearings or citizen’s petitions which will enable citizens to participate in the regulatory process for approving the new drug and register their objections.

Although there are some issues in the proposed bill but the change in the existing law is need of the hour. A mechanism should be built, where regulators should have proper communication links between different state regulators. Also, a set of uniform standards should be followed.