‘Spare cos with US, UK nod from strict cough syrup tests’
Last month, the Directorate General of Foreign Trade said that from 1 June only those cough syrups can be exported that pass quality tests at government-accredited testing labs.
PremiumNew Delhi: Pharma lobby Indian Drug Manufacturers Association (IDMA) has urged the government to exempt testing protocols from its new export policy for cough syrups if a manufacturer has approval from a highly regulated market like the US or UK.
Last month, the Directorate General of Foreign Trade said that from 1 June only those cough syrups can be exported that pass quality tests at government-accredited testing labs.
“This was discussed during the 8th Annual Conference on Pharmaceuticals & Medical Devices Sector with the secretary, department of pharmaceuticals that the cough syrup testing procedure may be followed for the export of cough syrup sent to the Semi-Regulated Markets only," said an IDMA communication to its members companies seen by Mint.
“However, if a manufacturer has an approval from USA, UK or any other highly regulated authority and goods are also meant for such markets, our regulators should not insist on such manufacturers to send cough syrup to any accredited laboratories for testing," said an official adding that this has been communicated to the member companies.
Since last October, there have been four different incidents where India-made cough syrups and eye drops have been linked to deaths, including of 66 children in Gambia.
Taking cognizance of it, the Union government has now tightened the regulations governing export of cough syrups. India exported cough syrups worth $17.6 billion in 2022-23 as against $17 billion in 2021-22. The country is the largest provider of generic drugs globally, supplying over 50% of global demand for various vaccines, about 40% of generic demand in the US and about 25% of all medicines in the UK. Queries sent to the spokesperson of the department of pharma and IDMA went unanswered.
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