The country’s drug regulatory body Central Drugs Standard Control Organization (CDSCO) on Wednesday directed the Drugs Controllers of all states and union territories to immediately stop the manufacture, sale and distribution of 35 unapproved fixed dose combination drugs (FDC drugs).
According to PTI news, these drugs include painkillers, nutrition supplements, anti-diabetes drugs. CDSCO has ordered strict compliance of the provisions of the rules. FDC drugs are those that contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio.
Serious threat to public health and safety
According to the news, the CDSCO has given these instructions after it found that some FDC drugs have been licensed for manufacture, sale and distribution without prior evaluation of safety and efficacy, posing a serious threat to public health and safety. In a letter sent on April 11, Drugs Controller General of India (DCGI) Dr. Rajiv Raghuvanshi cited a letter issued by his office in January 2013, which expressed concern about the granting of manufacturing licenses for the sale of FDC drugs falling under the definition of new drug in the country without proper approval from the DCGI.
A number of letters were issued from time to time
Several letters have been issued from time to time to the concerned state licensing authorities. At the same time, concern has also been raised over who has allowed the manufacturing and marketing of unapproved FDCs. In the letter issued in February, it has been said that it has come to the notice of the Directorate that some FDC drugs have not been licensed as per the provision of NDCT Rules 2019 under the Drugs and Cosmetics Act 1940. This poses a serious risk to public health and safety.
What was said on the show cause notice to the manufacturer
The letter underlines that the approval of such unapproved FDCs compromises patient safety and may lead to adverse drug reactions, drug interactions and other health hazards due to lack of scientific validation. On issuing a show cause notice to the manufacturer, he has stated that these licenses were granted by the respective drug licensing authorities and he has not violated any rules. The letter states that this has resulted in non-uniform enforcement of the provision of NDCT Rules 2019 under the Drugs and Cosmetics Act 1940 across the country.
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