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.
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.
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