Pharmexcil wants cough syrup mfg norms
The need is to issue norms for manufacture of cough syrups and limits of ethylene glycol and diethylene glycol
NEW DELHI : A day after the Union government revised the export policy related to cough syrup, the pharma export body—Pharmaceuticals Export Promotion Council of India (Pharmexcil)—chief Uday Bhaskar told Mint that the need of the hour is to issue comprehensive guidelines for the manufacturer with regard to cough syrups and specify the limits of ethylene glycol and diethylene glycol. Measures like sending cough syrup samples for testing to government laboratories will only delay the exports.
“I feel that there should be some guidelines on cough syrups and specifications for the limits of ethylene glycol and diethylene glycol for manufacturers of cough syrup. It is the responsibility of the manufacturer to comply with these guidelines and analyse the samples in their own testing laboratories and take Certificate of Analysis (CoA). Instead of fixing the responsibility of the manufacturers, we are coming up with stringent guidelines and asking everybody to send the samples to the government authorized labs, the need of the hour is to strengthen the drug regulatory system," he said.
In the name of controlling, they are creating one more compliance protocol which will delay the export process, he said. “Earlier it was free, now it will be a payment-based system. There are more than 2,000 manufacturers listed with Pharmexcil and most are manufacturing cough syrups."
A notification issued by Directorate General of Foreign Trade (DGFT), stated that from 1 June only those cough syrups can be exported that pass quality tests at Indian Pharmacopoeia Commission (UP), Central Drug Laboratory (Kolkata), Central Drug Testing Laboratory (Maharashtra, Telangana) Regional Drugs Testing Laboratory (RDTL Chandigarh & Guwahati) and National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited state drug testing laboratories for every batch.
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