Starting today, June 1, testing of cough syrups before export will be mandatory, the Drugs Controller General of India (DCGI) has asked specified state laboratories to examine such samples from manufacturers on "top priority and issue the test report at the earliest". The move came amid instances of quality concerns being raised abroad on cough syrups exported by Indian firms.
1)The government has notified new testing parameters for cough syrups to be exported from India and said these will require the production of a Certificate of Analysis (CoA) from specified laboratories.
2)The specified central government labs include Indian Pharmacopoeia Commission, regional drug testing lab (RDTL - Chandigarh), central drugs lab (CDL - Kolkata), central drug testing lab (CDTL - Chennai Hyderabad, Mumbai), RDTL (Guwahati)] and the NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited drug testing labs of state governments.
3) DCGI requested all central laboratories to give top priority in analyse the sample received from the manufacturers and issue the report immediately in order to avoid delays.
4) "State Drug Controllers are hereby requested to give instructions to your state-owned NABL accredited laboratories to analyse the samples received from the manufacturers of cough syrups for export purposes on top priority and issue the test report at the earliest," DCGI, wrote to thestate drug controllers.
5) The changes in the export of syrups will be effective from June 1.
6)India-made cough syrups were allegedly linked to the deaths of 66 and 18 children in Gambia and Uzbekistan, respectively, last year.
7)The Health Ministry had ordered a probe in the wake of the allegations and the production licence of the concerned pharma firms was suspended.
8) India is the largest provider of generic drugs globally,
9) India exported cough syrups worth USD 17.6 billion in 2022-23.
10) Globally, India ranks third in terms of pharmaceutical production by volume and 14th by value.
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