(a),(b),(c)&(d): Yes sir,details of drugs declared as spurious/substandard/adulterated/misbranded by Central Drug Testing Laboratories are regularly uploaded on CDSCO website (www.cdsco.nic.in) under the heading “Alert”. Details of such cases of Not of Standard Quality for month of November, 2019 is enclosed as Annexure-A.
Licence for manufacturing, sale & distribution of drugs are 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 above cases have been forwarded to the State Drugs Controllers of the concerned State where the drug was manufactured for taking necessary action.
(e) & (f):Government have taken various regulatory measures to ensure the quality of medicines in the country.
Details are as under;
1. 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 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 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.
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 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, 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.
Further, as per the information received from various State/U.T. Drugs Controllers the No. of drugs samples tested, No. of drugs samples declared sub-standard quality, spurious/ adulterated drugs, its percentage and action taken during last five years is enclosed as Annexure B.
Such information received from various Zonal/Sub-zonal offices of CDSCO is enclosed as Annexure C.
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