Drug controller investigating medicine exported to Sri Lanka

The Drug controller of India is investigating a Gujarat-based pharmaceutical company after receiving complaints from Sri Lanka that a steroid eye drop manufactured by the firm has been linked to adverse events including loss of eye sight.
About the information:
  • The prednisolone eye drop was administered to patients in Sri Lanka reportedly after undergoing cataract Surgery.
  • The eye drop has been linked to eye infection in more than 30 people in Sri Lanka.
  • In India too, there were 68 cases of the infection reported from 16 states, leading to at least three deaths, eight cases of vision loss, and four cases of removal of eyeballs.
Investigations involved:
  • The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has issued a notice to the company seeking details of the importer, those who the drug has been supplied to, and manufacturing licence and product permission.
  • It was also advised to the company to investigate the reasons for contamination of the alleged product at your end and update with their findings at the earliest to take necessary action.
  • Till the submission of the enquiry report by the company, it is not allowed to export drug without a Registration-cum-Membership Certificate (RCMC) from Pharmexcil.
Drug regulations in India:
  • Central Drugs Standard Control Organisation (CDSCO):
    • It is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act of 1940.
    • It works under the Ministry of Health & Family Welfare the National Regulatory Authority (NRA) of India.
    • Under the Drugs and Cosmetics Act, CDSCO is responsible for –
      • Approval of Drugs.
      • Conduct Clinical Trials.
      • Laying down the standards for Drugs.
      • Control over the quality of imported Drugs in the country.
      • Coordination of the activities of State Drug Control Organizations.
    • Further CDSCO along with state regulators, is jointly responsible for the grant of licences to certain specialised categories of critical Drugs such as vaccines and sera, etc.
Role of Drug Controller of India:
  • DCGI is the head of the department of the CDSCO of the Government of India responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India.
  • DCGI also sets standards for the manufacturing, sales, import, and distribution of drugs in India.

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