Health ministry plans drug licensing changes to ensure drug safety

Proposals aim to standardise drug manufacturing practices after a few Indian medicines were flagged as 'substandard' by the WHO

The Union Health Ministry has proposed significant alterations to its drug licensing programme in an effort to standardise practices across the country and enhance drug safety, according to a report by Mint.

 

The proposal also aligns with recommendations from a government expert panel that stressed the importance of consistent documentation and dossier-based approval processes for domestically manufactured drugs to ensure uniform quality and safety standards. The health ministry has shared the draft with the Central Drugs Standard Control Organisation (CDSCO) and is awaiting feedback.

 

This move comes after allegations that cough syrups produced in India were connected to deaths overseas. The World Health Organisation (WHO) has issued alerts over India-made syrups, flagging "substandard" quality.

 

 

The lack of uniformity in existing regulations has led to inconsistent enforcement, underdeveloped testing infrastructure, and disparities in implementing regulations. The main issue seems to extend from the fact that both the central government and individual states issue licenses for drug manufacturing in India.

 

Bringing uniformity to the drug regulatory framework is expected to guarantee drug safety, effectiveness, and quality. This standardisation can also ensure that pharmaceutical companies, particularly smaller ones, strictly adhere to good manufacturing practices (GMP) guidelines, according to Atul Nasa, former drug controller of Delhi, as reported by Mint.

 

Indian health officials are concerned that contaminated medicines could further damage the country's reputation as a global pharmaceutical supplier. 

 

The health ministry believes that uniform implementation of the Drugs and Cosmetics Act, 1940 provisions will guarantee drug quality. A state drug controller recommended nationwide implementation of document-based drug licencing, following the expert panel's deliberation.

 

The plan includes uniform implementation of market surveillance to monitor the quality of medicines throughout the supply chain. In India, over 100,000 drug samples are tested annually, but a lack of coordination between states and the Centre can cause delays in investigations and subsequent actions. The objective is to bring uniformity to the entire drug regulatory system.