Atmanirbhar Bharat and Pharmaceutical Sector Challenges
The concept of Atmanirbhar Bharat is an aspirational goal for India, especially within the pharmaceutical sector. However, its success relies on a robust quality control framework.
Challenges Faced
- India aims to enhance its global presence in pharmaceuticals, but quality issues pose significant threats.
- Concerns over the quality of cough syrups have arisen multiple times, impacting trust in Indian pharmaceuticals.
Recent Incidents and Government Response
- The Union Health Ministry has demanded strict compliance with revised Schedule M norms for Indian drug manufacturers.
- A Tamil Nadu Drugs Control Department report found above permissible levels of diethylene glycol (DEG) in samples of Coldrif cough syrup, suspected in the deaths of at least 16 children in Rajasthan and Madhya Pradesh.
- While initial tests in the affected states did not detect DEG, it was found in samples from Tamil Nadu.
- The report highlighted issues in Good Manufacturing and Good Laboratory Practices at the production facility, with non-pharmacopoeial grade propylene glycol used as an excipient, possibly contaminating the drug with nephrotoxic substances like DEG and ethylene glycol.
- The Central Drugs Standard Control Organisation has recommended revoking the manufacturing licence of the company involved.
- A doctor who prescribed the syrup to affected children in Madhya Pradesh was also arrested.
Recommendations for Improvement
- India must adopt a zero-tolerance policy towards poor-quality drugs and implement stringent monitoring.
- Proactive measures are essential—action should not only be taken post-incident.
- Existing frameworks for Good Laboratory Practices should be enforced stringently with regular, surprise inspections of drug batches, ensuring penalties for every violation.
- The government must communicate that any negligence endangering lives is unacceptable.
