New Delhi: The Union Health Ministry has launched a special drive to check the quality of drugs manufactured by companies in India with an aim to ensure their safety and effectiveness.
The drive is being carried out following several reports of sale of counterfeit and substandard medicines. The recent controversy surrounding Maiden Pharmaceuticals Ltd’s cough syrup that killed 66 children in Gambia raised concerns about the quality of Indian medicines.
Preventing the distribution of substandard drugs is important for maintaining India’s reputation as the “Pharmacy of the World”. India has seen pharmaceutical exports more than double to $24.5 billion in the past decade. The deaths in Gambia damaged India’s reputation, although India insisted that the drugs manufactured by Maiden were not responsible. However, a Gambian parliamentary panel recently stated that Maiden’s cough syrup was responsible for the deaths of the children due to acute kidney injury.
“We are running a special drive to inspect pharmaceutical companies. Our drug regulator is going to every drug manufacturing company for investigation. However, regulatory testing of drugs and medicines continues to occur. I read many news reports about fake and substandard medicines being found here and there. So, I directed the agencies to launch a special drive on this,” Health Minister Dr Mansukh Mandaviya said in an interview.
An action plan was drawn up for nationwide inspection of manufacturing units that have been identified as at risk of adulterating or counterfeiting drugs classified as Standard Quality (NSQ). The Drug Control Administration needs to ensure that the manufacturing units comply with the requirements of the Drugs and Cosmetics Act, 1940 and the regulations made thereunder, particularly the Good Manufacturing Practices (GMP).
The Union Health Ministry on Tuesday said that the Central Drugs Standard Control Organization (CDSCO) has started joint inspection of drug manufacturing units with state drug control administrations as per the risk-based approach.
“We have started action to inspect pharma units. We have identified two such drug manufacturing units. There is a proper proforma based on which we coordinated the drive-in with the central government. Delhi Drugs Controller KR Chawla said, very soon we will be able to submit our report to CDSCO.
Around 84,874 drug samples were tested in 2020-21, out of which 2,652 samples were declared not of standard quality (3.12%), the state’s Health and Family Welfare Minister, Bharti Praveen Pawar told the Rajya Sabha during the winter session of Parliament. were done. , and 263 were declared spurious while 0.31% of the drugs were adulterated.
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