Govt approved Rs 1750 crore proposal for strengthening drug regulatory system

New Delhi: The issue of regulating the manufacture and circulation of spurious/substandard/adulterated/misbranded drugs was recently brought up in the Parliament during the Budget Lok Sabha session, wherein, the Minister in the Ministry of Chemical and Fertilizer, DV Sadananda Gowda informed that the Government has approved a proposal for strengthening the drug regulatory system in the country, both at the level of Central and the State Governments at a total expenditure of Rs 1750 crores. Out of this, Rs 900 crore is for strengthening the central drug regulator structure and Rs 850 crore is for strengthening the drug regulatory system in the states.

This came while responding to a query raised by members, Kirti Vardhan Singh and Manoj Kishorbhai Kotak, who asked whether the Government is aware of the fact that the Central Drugs Standard Control Organisation (CDSCO) has flagged 37 batches of medicines including crucial ones for failing quality test in the month of November 2019 and its details.

They further sought whether public sector enterprises manufacturing medicines are also among the defaulters and the steps likely to be taken by the Government to prevent such incidents in future so as to maintain the quality of the medicines. The members also asked about the action taken by the Government on fake/ imitation of a genuine medicine during the last five years.

Responding to the queries, Gowda stated that the Government has taken various regulatory measures to ensure the quality of medicines in the country such as;

• The Drugs and Cosmetics Act, 1940 was amended under Drugs & Cosmetics (Amendment) Act 2008 to provide stringent penalties for manufacture of spurious and adulterated drugs. Certain offences have also been made cognizable and non-bailable.

• Guidelines for taking action on samples of drugs declared spurious or not of standard quality in the light of enhanced penalties under the Drugs & Cosmetics (Amendment) Act, 2008 were forwarded to the State Drugs Controllers for uniform implementation.

• The States / UTs were requested to set up special courts for trial of offences under the Drugs and Cosmetics Act for speedy disposal. So far, 33 States have already set up designated special Courts for trial of cases related to spurious and sub-standard drugs.

• The number of sanctioned posts in the Central Drugs Standard Control Organization (CDSCO) has been increased from 111 (in April 2008) to 511 (in June 2019). The testing capacities of Central Drugs Testing Laboratories under CDSCO are being constantly strengthened to expedite testing of drug samples in the country. On 3.4.2017, in order to ensure the 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 the oral dosage form of drugs falling under the Category II and Category IV of the Biopharmaceutical Classification System.

• On 27.10.2017, 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. 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 the 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.

• On 10.04.2018, 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, the safety of excipients etc. to the State Licensing Authority before grant of product manufacturing license by the Authority.

• Draft Rules have been published vide GSR 999 (E), dated 5th 10.2018 to amend the Schedule M of the Drugs and Cosmetics Rules, 1945 to make it more comprehensive at par with the WHO-GMP guidelines.

"The Government has approved a proposal for strengthening the drug regulatory system in the country, both at the level of Central and the State Governments at a total expenditure of Rs.1750 crores. Out of this, Rs. 900 crore is for strengthening the central drug regulatory structures and Rs.850 crore is for strengthening the drug regulatory system in the States. During the years 2016-17 and 17-18, Rs. 128.39 crore was released under the Central component whereas Rs. 87.90 crore was allocated during 2018-19 under this component. Rs. 82.90 crore was allocated during the year 2019-20. Under the State component, Rs. 81.36 crore was released during 2016-17 and 17-18 whereas Rs. 206 crore was allocated during 2018-19 under this component," the Minister further added.

He further elaborated on the questions related to spurious drugs while mentioning that the details of drugs declared as spurious/substandard/adulterated/misbranded by Central Drug Testing Laboratories are regularly uploaded on CDSCO website (www.cdsco.nic.in). He also furnished the details of the drugs flagged for the month of November by CSDCO.

Also Read: CDSCO Declares 37 Drug Samples Including Ibuprofen, Vitamin B-Complex As Not Of Standard Quality

"Licence for manufacturing, sale & distribution of drugs is granted by the State Licensing Authorities appointed by respective State Governments. State Governments are empowered to take action on violations of any of the provisions of Drugs & Cosmetics Act, 1940 and Rules made thereunder. All the above cases have been forwarded to the State Drugs Controllers of the concerned State where the drug was manufactured for taking necessary action," Gowda said in his response.