CHENNAI: The new Drugs, Medical Devices and Cosmetics Bill, 2023 by the Union Government proposes that the drug manufacturers apply to the Central Drugs Standard Control Organization (CDSCO) for licensing requirements, but the State stakeholders and pharmaceutical industries are against the move as it would increase the hassle for the small scale manufacturers.
The CDSCO is proposed to regulate the manufacture of drugs or cosmetics instead of State drug regulators to ensure uniformity in the licensing process as per the revised draft of the Bill. "We will have to go to Delhi for all the procedures and for small scale manufacturers it should not be mandatory because State themselves can take control of the regulations," said a representative from a small drug manufacturing unit in Tiruvallur.
Meanwhile, as per the new draft Bill, the sale of drugs, cosmetics and medical devices will continue to be monitored and regulated by the State Government. After the bill was brought up last year, the State Druggists and Chemists had raised the issue saying the small manufacturers have to apply for endorsement of combined drugs of more than one molecule to CDSCO Delhi. It will be burdening to the small manufacturers and also this system indirectly affects the State Government rights.
"The State government should oppose the proposal of the Union Government because the functioning of the existing process in error free and small manufacturers need not hassle so much for licensing. We have submitted a letter to the Chief Minister's office in this regard. If the licensing remains under the control of the State government, the principle of self-governance of the State would be restored and the small production companies will not be affected, " said S Ramachandran, former secretary of Tamil Nadu Druggists and Chemists Association.
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