Against the backdrop of quality concerns involving some medicines from the country, the Union Health Ministry said, it has increased the number of posts at the Central Drugs Standard Control Organization (CDSCO), besides taking stringent steps on manufacturing as well.

The number of sanctioned posts in CDSCO has been increased from 111 in 2008 to 931 till date, Union Minister of State for Health and Family Welfare, Dr Bharati Pravin Pawar said in a written reply in the Lok Sabha. The increase was across mixed functions, an official source said.

Further the Minister said, to ensure the efficacy of drugs, the Drugs and Cosmetics Rules, 1945 had been amended and applicants would have to submit the result of bioequivalence studies along with the application for grant of a manufacturing license for an oral dosage form of some drug.

The amendment also makes it mandatory, that a manufacturing establishment be inspected jointly by the drug inspectors of Central and State Governments, before the manufacturing license is granted. Also, it is now mandatory that the applicants submit evidence of stability, safety of excipients, etc. to the State Licensing Authority before receiving grant of manufacturing license by the Authority, she added.

Pawar said, “State Licensing Authorities were empowered to take action in case of violation of any license keeping in mind the regulation from the respective State Government which could enforce the Drugs and Cosmetics Act upon failure to comply”.

Outlining other measures, she said, the Drugs and Cosmetics Act, 1940 was amended under Drugs & Cosmetics (Amendment) Act 2008, to provide stringent penalties for the manufacture of spurious and adulterated drugs. Certain offences have also been made cognisable and non-bailable, she said. States and UTs have set up special Courts for the trial of offences under the Drugs and Cosmetics Act for speedy disposal, she added.

Uniform administration

The CDSCO coordinates activities of State Drug Control Organisations and through the Drugs Consultative Committee (DCC) meetings held with States, it provides uniformity in administration of the Drugs and Cosmetics Act, she said.

The Centre has further amended the Drugs Rules 1945 (on December 28, 2023) to revise Schedule M related to Good Manufacturing Practices and requirements of premises, plant and equipments for pharmaceutical products.

In order to ensure the quality of drugs and to assess the regulatory compliance of drug manufacturing premises in the country, the CDSCO along with State Drugs Controllers, conducted risk-based inspections of 275 premises. The firms were identified based on risk criteria, like number of drugs declared as Not of Standard Quality, complaints, criticality of the products, etc. Based on findings of inspections, more than 250 actions, like issuance of show cause notices, stopping production order, suspension, cancellation of licenses/product licenses etc, have been taken by State Licensing Authorities, she said.