Taking steps to strengthen drug regulatory system, says govt

New Delhi: Union Minister of State for Chemicals and Fertilizers, Mr Mansukh L. Mandaviya, has said that drugs manufactured in the country, irrespective of whether branded or generic, are required to comply with the same standards as prescribed in the Drugs and Cosmetics Act, 1940 and rules made for ensuring their quality.

“The inspectorate staffs have been instructed to keep a vigil and draw samples of drugs for test and analysis to monitor the quality of drugs moving in the country,” the Minister said while answering a question on the topic recently in the Parliament.

Mr Mandaviya revealed that the number of sanctioned posts in Central Drugs Standard Control Organization (CDSCO) have been increased from 111 in 2008 to 510 in 2018. “The testing capacities of Central Drugs Testing Laboratories under CDSCO are being constantly strengthened to expedite testing of drug samples in the country,” he added.

The Union Minister went on to give the examples of the amendments made to the Drugs and Cosmetics Rules, 1945 in last two years to make it more effective.

On 3rd April 2017, in order to ensure efficacy of drugs, the Drugs and Cosmetics Rules,1945 have been amended providing that applicant shall submit the result of bioequivalence study along with the application for grant of manufacturing license of oral dosage form of drugs falling under the Category II and Category IV of the Biopharmaceutical Classification System, stated Mr Mandaviya.

On 27th October 2017, the Drugs and Cosmetics Rules, 1945 have been amended vide Gazette notification no. G.S.R. 1337 (E) making it mandatory that before the grant of manufacturing license, the manufacturing establishment is to be inspected jointly by the Drugs Inspectors of Central Government and State Government, he said. “The licensed manufacturing premises shall be inspected jointly by the Drugs Inspectors of Central Government and State Government to verify the compliance with the conditions of license and the provisions of the Drugs & Cosmetics Act and Rules for not less than once in three years or as needed as per risk based approach,” explained Mr Mandaviya.

On 10th April 2018, the Drugs and Cosmetics Rules, 1945 have been amended vide Gazette notification no. G.S.R. 360 (E), making it mandatory for all drugs, that the applicants shall submit evidence of stability, safety of excipients etc. to the State Licensing Authority before grant of product manufacturing license by the Authority.

Further, Mr Mandaviya informed that the manufacturing, sale and distribution of Drugs in the country are regulated under the provisions of Drugs & Cosmetics Act, 1940 and Rules, 1945 made thereunder through a system of licensing and inspection. “License for manufacturing, sale and distribution of Drugs are granted by State Licensing Authorities appointed by respective State Governments. As per the Drugs & Cosmetics Act, 1940, Drugs Inspectors are authorized to take samples of any drug for test/analysis,” he said.

Accordingly, States and Central Drugs Inspectors draw the sample from market/supply chains and get it tested in the Government Drugs Testing Laboratories. If the samples declared Not of Standard Quality/ Spurious drugs, action are initiated as per the provisions of said Act and Rules. Licensees are required to comply with all the condition of license and follow the Good Manufacturing Practices (GMP) as prescribed under said Rules to ensure that the drugs manufactured by them are safe and of standard quality, the Minister added.