Regular review of CDSCO functioning, deaths due to spurious drugs: Minister

New Delhi: Through a recent reply, the Union Health Minister, Dr Harsh Vardhan informed the Parliament about the regular review of the function of the apex drug regulatory body of India, Central Standard Control Organisation (CDSCO) and the measures taken to address various issues. Besides, Dr Vardhan also spoke about the query related to adverse events/ death of patients due to the use of spurious/counterfeit medicine.

This came in response to a query raised by Sunil Kumar Mondal during a Lok Sabha session, who sought whether the Government has reviewed the functioning of CDSCO and the related outcomes. He further asked about the details of any complaint has been registered regarding the death of any person due to use of spurious/counterfeit medicine during the last five years and the current year.

In a written reply, Dr Vardhan stated that the Government of India is continuously involved in monitoring/review of the functioning of CDSCO to strengthen the Drugs regulatory system.

"Earlier in 2011 and 2012, Department Related Parliamentary Standing Committee on Health and Family Welfare reviewed the functioning of CDSCO in respect of various aspects such as mandate and structure of CDSCO, role of the State drug regulatory authority, capacity building of CDSCO and Central & State Drug Testing Laboratories, New Drugs and Clinical Trial approval, banning of drugs, issue of granting licence of Fixed Dose Combinations without approval of Drugs Controller General India (DCGI), issues regarding similar brand names, post-marketing surveillance, spurious/sub-standard drugs, advertisement of prescription drugs in media, etc," the minister added.

Further, during the last five years, based on regular review of CDSCO and its functioning, a number of measures have been taken to address these issues which include;

• Strengthening of infrastructure and manpower of CDSCO;


• Framing of Medical Devices Rules, 2017;


• New Drugs and Clinical Trials Rules, 2019;


• Online submission and processing of various applications under SUGAM portal;


• Evaluation of applications of clinical trials;


• New drugs and Investigational New Drug (IND) including r-DNA derived products and vaccines;


• New medical devices in consultation with the Subject Experts Committees/IND committee;


• Amendments in Drugs and Cosmetics Rules including the prohibition of advertisement of Schedule H, H 1 & X drugs and provision to address issues related to similar brands etc.

In the context of the question regarding the death of any person due to use of spurious/counterfeit medicine during the last five years and the current year, Dr Vardhan mentioned that as per information received from State/UT Drugs Controllers, no complaint has been registered regarding the same.

He added that the manufacture, sale and distribution of drugs in the country is regulated under the provisions of Drugs & Cosmetics Act, 1940 and Rules, 1945 thereunder through a system of licensing and inspection. Licenses for manufacture, sale and distribution of drugs are granted by the State Licensing Authorities (SLAs) appointed by respective State Governments. SLAs are legally empowered to take stringent action against violation of provisions of the Act and Rules.

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