With India making pre-export testing of cough syrups mandatory from June 1, the Drugs Controller General of India (DCGI) has asked designated government laboratories to test such samples from manufacturers on “top priority and issue the test report at the earliest”.
Cough syrup exporters will have to produce a certificate of analysis issued by a government laboratory before exporting the product from June 1, the Directorate General of Foreign Trade (DGFT) said in a notification on Monday. The move comes in the wake of quality concerns being raised abroad about cough syrups exported by Indian companies.
“The export of cough syrup shall be permitted with effect from 1 June 2023, subject to testing of export samples and production of certificate of analysis issued by one of the laboratories,” the notification said.
On Wednesday, the country’s top drug regulator, the DCGI, wrote to state drug controllers of Gujarat, Karnataka, Kerala, Madhya Pradesh, Maharashtra, Jammu and Kashmir and Uttarakhand and central laboratories, referring to the notification issued by the commerce and industry ministry on the export policy for cough syrups.
“The State Drug Control Officers are hereby requested to issue instructions to their State NABL accredited laboratories to analyse the samples received from the manufacturers of cough syrups for export on top priority and issue the test report at the earliest,” the letter said.
It requested all central laboratories to analyse the samples received from the manufacturers on top priority and issue the report immediately to avoid any delay. “All state licensing authorities are requested to forward the e-mail IDs of their state NABL accredited laboratories to this office by return mail,” the letter said.
The central government laboratories mentioned include the Indian Pharmacopoeia Commission, Regional Drug Testing Laboratory (RDTL – Chandigarh), Central Drug Laboratory (CDL – Kolkata), Central Drug Testing Laboratory (CDTL – Chennai, Hyderabad, Mumbai), RDTL (Guwahati) and NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited drug testing laboratories of the state governments.
The Indian pharmaceutical industry is a major manufacturer and exporter of medical products across the world – from highly developed countries to low- and middle-income countries (LMICs).
India is the world’s largest supplier of generic medicines, accounting for more than 50 percent of global demand for various vaccines, about 40 percent of generic demand in the U.S., and about 25 percent of all medicines in the United Kingdom.
Cough syrups manufactured in India were reportedly linked to the deaths of 66 and 18 children in The Gambia and Uzbekistan, respectively, last year. India exported cough syrups worth $17.6 billion in 2022-23, up from $17 billion in 2021-22.
Globally, India ranks third in pharmaceutical production by volume and 14th by value.
The industry comprises a network of 3,000 drug manufacturers and about 10,500 manufacturing facilities. It facilitates the availability and supply of high-quality, affordable, and accessible medicines around the world.
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