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3 private labs get nod to test cough syrups

NEW DELHI : The Drugs Controller General of India (DCGI) Rajeev Raghuvanshi has granted permission to three National Accreditation Board for Testing and Calibration Laboratories (NABL)- accredited private labs to conduct tests on cough syrups for exports.

The private labs are: Bee Pharma Labs (Mumbai), Oasis Test House (Ahmedabad) and Shriram Institute for Industrial Research (Delhi). Prior to this, only government labs were authorised to test cough syrups for export.

The DCGI is seeking to avoid delays in testing and reducing the burden on government labs. Testing the cough syrups to detect Di-Ethylene Glycol and Ethylene Glycol contamination takes at least 15 days, said experts.

This initiative is in response to concerns over cough syrups made in India failing its quality check in other countries, following the death of children in Uzbekistan and The Gambia.

“It has been decided with the approval of ministry of health and family welfare to include three NABL-accredited private testing laboratories for testing cough syrups that are to be exported by manufacturers, authorised person of manufacturers, and exporters apart from 14 NABL-accredited government labs,” Raghuvanshi said in a communication to all state drug controllers.

In June, the Centre changed the exports policy for cough syrups making it mandatory for testing before supplying to other countries. The pharma companies are now mandated to export cough syrups after producing a certificate of analysis.

Out of the over 10,500 drug manufacturing facilities operating in India, around 8,500 are MSMEs, out of which only 2,000 facilities have obtained the good manufacturing practices certification from the World Health Organization.

Queries sent to the health ministry spokesperson did not elicit any response.

The crackdown follows incidents of cough syrups failing quality checks in foreign countries.

India, the largest provider of generic drugs globally, exported cough syrups worth $17.6 billion in 2022-23 as against $17 billion in 2021-22. India’s pharma export body Pharmexcil has over 2,000 manufacturers registered with it, and most are manufacturing cough syrups.

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Updated: 16 Sep 2023, 12:12 AM IST

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