Date: Monday, July 31, 2023, 08:00 Hrs [IST]
Location: New Delhi
The Indian government’s plan to introduce the New Drugs, Medical Devices and Cosmetics Bill, 2023 in the current parliamentary session has sparked unease among industry members. The proposed bill is intended to replace the age-old Drugs and Cosmetics Act of 1940, aiming to regulate the import, manufacturing, distribution, and sale of drugs, medical devices, and cosmetics while ensuring safety, quality, and efficacy.
However, industry representatives have expressed reservations about the potential centralization of licensing and other powers under the control of the Central drug regulatory authority. They fear that such a move could adversely affect small and medium-sized pharmaceutical companies. Currently, the Centre formulates legislations, and the States implement and regulate the manufacture and sale of medicines. The new bill may shift more powers to the Centre due to concerns regarding drug quality raised both domestically and internationally.
One particular concern is related to the lack of information about the details of the New Drugs, Medical Devices and Cosmetics Bill, 2023, which has been listed for tabling in Parliament during the ongoing session. Moreover, the bill has not been presented to the Parliamentary Standing Committee for necessary discussions and debates.
An anonymous industry insider highlighted specific sections of the proposed bill that create a Central Licensing Approving Authority and grant the Central Government the authority to control the manufacture and sale of medicines through notifications. Another section empowers the Central government to cancel any license. Critics argue that such changes could potentially require moving the subject of drugs to the Union List, as per the roles defined in the Indian Constitution for the Centre and States.
Another point of contention raised by industry stakeholders is the alleged corruption within the central drug regulatory agency. They assert that the qualifications and eligibility of CDSCO (Central Drugs Standard Control Organization) inspectors are the same as those appointed by state governments. However, CDSCO inspectors enjoy more freedom, which, according to experts, increases corruption levels within the system.
The proposed changes may also have adverse effects on Micro, Small, and Medium Enterprises (MSMEs) in the sector while seemingly favoring large pharmaceutical companies and multinationals.
The lack of adequate discussions with major stakeholders prior to introducing and passing the legislation is another concern raised by industry bodies like the Association of Indian Medical Device Industry (AiMeD) and the Medical Technology Association of India (MTaI). They stress the need for engaging with the industry to gather feedback and suggestions before finalizing the bill.
In response to mounting concerns, the minister for health and family welfare, Dr. Mansukh Mandaviya, has assured AiMeD that the government will hold discussions with stakeholders regarding the bill. However, as the industry anxiously awaits further developments, the fate of the proposed New Drugs, Medical Devices and Cosmetics Bill remains uncertain.