New licensing policy to boost drug safety
NEW DELHI : The Union health ministry has proposed sweeping changes to its drug licensing programme, aiming for uniformity across India to boost drug safety, after cough syrups made in the country were allegedly linked to the deaths of children overseas, two people familiar with the development said. The proposal also follows a government expert panel emphasizing the need for uniform implementation of documentation and dossier-based approval processes for drugs manufactured in the country to ensure consistent quality and safety.
The health ministry has shared the draft with the Central Drugs Standard Control Organization (CDSCO) for inputs. A lack of uniformity in rules, officials noted, results in poor enforcement of regulations, inadequate development of testing infrastructure, and discrepancies in the competence of regulatory officials.
The lack of uniformity is mainly because the central government and the states both issue licences for drug manufacturing in India. “By bringing uniformity in the drug regulatory mechanism, the government will be able to ensure safe, effective and quality drugs.
It will make sure that pharma companies especially the smaller ones, are strictly following the GMP guidelines," said former drug controller of Delhi Atul Nasa. Indian health officials fear that contaminated medicines could seriously harm the country’s reputation as a supplier of medicines to the world and have taken several steps to enhance the safety of drugs.
Last year, the World Health Organization found that cough syrups made in India contained toxins, diethylene glycol and ethylene glycol, linked to the deaths of at least 70 children in The Gambia. India, however, denied any connection between the syrups and the deaths.
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