Trade, Import, Export for MSMEs: After incidents of death linked to the consumption of cough syrups exported from India were reported in Uzbekistan in December last year and in Gambia (West Africa) in March this year, the Indian government has made testing of export sample for cough syrup makers mandatory, effective June 1, 2023.
The government notified the move in the amendment of Chapter 30 of Schedule 2 of the ITC (HS) Export Policy for cough syrup makers on May 22 to get a Certificate of Analysis (CoA) from only authorised government laboratory as a permit to export syrups.
However, according to experts, this may increase the turnaround time for testing and clearance of samples which may lead to some impact on business.
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“Sample testing was compulsory previously as well, however, in-house testing was allowed which used to take only 48 hours as manufacturers had set up labs in their own production units. The time taken for testing depends on compounds in the medicine — higher the compounds, the more time it takes for testing,” Amit Kapur, General Secretary, Pharmaceutical Manufacturers Association, Amritsar told FE Aspire.
However, with the government making it mandatory for sample testing from only recognised state labs, it may take up to 12-15 days to get the clearance for export, according to Kapur.
“This would increase the time taken to supply goods. However, considering the unfortunate events of the past, it is a welcome move by the government,” Kapur added.
According to the notification, Indian Pharmacopoeia Commission, Ghaziabad, CDL Kolkata, CDTL Chennai, CDTL Mumbai, CDTL Hyderabad, RDTL Chandigarh, RDTL Guwahati and any NABL-accredited state drugs testing laboratory are authorised to test the export sample and issue permit for export.
Arjun Seth, Managing Director at pharma product manufacturing firm Systacare Remedies told FE Aspire that testing and clearance should not take more than 10 days, “but it would be great if the government-recognised labs can do it in five days since in-house testing takes a maximum of three days.”
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With respect to the cost of testing, Seth said the new ruling will not make a difference but the time lag may add to the logistics cost.
On the positive side, certification is likely to help improve product quality for small syrup manufacturers as for a majority of such manufacturers in India, the prime markets are Asian and African countries with easier regulations vis-a-vis Western countries, Seth added.
According to the government’s Niryat portal, Indian pharma and drug industry exports stood at $25.36 billion dollars in FY22-23 while as per a PTI report, India exported cough syrups worth $17.6 billion in 2022-23 in comparison to $17 billion in 2021-22.