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<\/p>\nAfter reports of contamination in cough syrups sent from the country, India is considering a system to test them before exporting.<\/p>\n
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It is learnt that the Central Drugs Standard Control Organisation (CDSCO) has sent a proposal to the Union health ministry on this.<\/p>\n
The idea is to test the medicines at government labs before exporting.<\/p>\n
No decision on the matter has yet been taken, said sources.<\/p>\n
There are five Central Drugs Testing Laboratories under the CDSCO — in Kasauli, Kolkata, Hyderabad, Chennai, and Mumbai — and two regional drug testing laboratories — in Guwahati and Chandigarh.<\/p>\n
Apart from this, the Indian Pharmacopoeia Commission Laboratory may also be used.<\/p>\n
Industry sources said reports of labs accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL) may be considered a valid certificate of analysis (CoA) by manufacturers and exporters.<\/p>\n
There are over 2,300 medical-testing laboratories accredited by the NABL as of January last year.<\/p>\n
A pharma industry veteran said the government might consider making glycol testing compulsory for all manufacturers of syrups and solvents.<\/p>\n
“Right now the Indian Pharmacopoeia does not require a mandatory glycol testing certificate.<\/p>\n
“CoAs are provided by the manufacturing entity.<\/p>\n
“Making the glycol test part of the other mandatory tests required for a CoA will eliminate the root of the problem of contamination,” the person said.<\/p>\n
At present, the manufacturer of a pharmaceutical product obtains a certificate of pharmaceutical product (CoPP) from the state Food and Drug Administration.<\/p>\n
A CoPP is given after due inspection, and manufacturers are supposed to submit CoAs with their consignments, whether they are for domestic market consumption or export.<\/p>\n
Another industry source said India exported to 200 countries, and it would be impossible to test every batch of cough syrup before sending out.<\/p>\n
“Countries like Nigeria have their own testing facilities in the countries of origin of consignment.<\/p>\n
“European countries test them at the point of entry and the US do tests randomly at the port of entry.<\/p>\n
“The Indian government agency has so far not been involved in testing export batches.<\/p>\n
“This can be time-consuming if done only at government labs,” the person said.<\/p>\n
The move comes at a time when cough syrups and eye-drops from India have come under fire from several countries including the Gambia and Uzbekistan.<\/p>\n
These incidents have harmed the image of India as an exporter of drugs to the globe, the industry said.<\/p>\n
The Centre is thus contemplating measures to curb medicines of compromised quality entering the global supply chain, the person said.<\/p>\n
The UP drug controller has cancelled the manufacturing licence of Marion Biotech, whose cough syrup Dok-1 was linked to the deaths of 18 children in Uzbekistan.<\/p>\n
The Pharmaceutical Exports Promotion Council (Pharmexcil) has suspended memberships of Marion Biotech and Maiden Pharmaceuticals, making them ineligible for incentives under the Market Access Initiative Scheme.<\/p>\n