Gambia cough-syrup deaths a 'wake-up call’ to streamline pharma regulatory system: Expert

New Delhi:

In the wake of the Gambia cough-syrup-related deaths, the Indian regulatory apex body Central Drugs Standard Control Organisation (CDSCO) has initiated an investigation into the matter. Sonepat-based Maiden Pharmaceuticals, the manufacturer and exporter of the cough syrups in question has been directed by the CDSCO and Haryana State Drugs Controller to stop all activities on grounds of deficiencies found in the preliminary investigation.

The Ministry of Health & Family Welfare has appointed a four-member committee for further investigation. The committee will, after examining and analysing adverse event reports, causal relationships and all related details shared by the World Health Organisation (WHO), suitably advise and recommend Drug Controller General of India (DCGI) about the further course of action. The committee may co-opt any other technical expert as deemed necessary. The four-member committee comprises the following technical experts: Dr YK Gupta, Vice Chairperson, Standing National Committee on Medicines (Chair), Dr Pragya D Yadav, NIV, ICMR, Pune, Dr Arti Bahl, Division of Epidemiology, NCDC, New Delhi and AK Pradhan, JDC(I), Central Drugs Standard Control Organisation (CDSCO).

Deaths caused by the consumption of spurious drugs have been on the rise. These tragedies raise questions for all the stakeholders of the pharma industry in India and globally. Tragedies related to contaminated or spurious medicines need to be avoided. Sharing his views on the need for streamlining the regulatory system, Dr Appaji PV, Founder & Former Director General, Pharmexcil India, Former Director, NPPA, Govt of India, Ex-officer, Drugs Control Department, GOVT of AP /Telangana, said, “They are good but streamlining is required. Given the distributed powers between the central and state governments and no one would like to agree for one uniform organisation for the whole country, the best option would be to create one national civil services organisation for healthcare and follow the same principles being adopted for IAS etc such trained officers will ensure uniform regulatory compliances in all states.”

Commenting on the implementation of anti-counterfeiting solutions, authentication features and traceability solutions Dr Appaji PV stated, “ The government's decision to impose barcoding on the top 300 medicines sold in the country is very appropriate and it should start soon and can be expanded later.”

The deaths of 66 children in Gambia has highlighted the need for importing countries to implement vigilant and strict measures while importing medicines from other nations. It is true that regulators of exporting country also cannot take full load and responsibility. The importing country should be advised to appoint their India-based quality testing agencies to check and issue a quality certificate for each exported consignment. The customs of importing authorities will give clearance only after verification of the quality certificate,” concluded Dr Appaji PV.