J&K can now participate in drug, vaccine trials

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Government Medical College (GMC) Srinagar has secured approval for its ethical committee from Central Drug Standards Control Organization (CDSCO), rendering it eligible for participation in drug and vaccine trials as well as other medical research activities.

CDSCO, the central licensing authority registered and permitted the ethical committee of GMC Srinagar to perform the functions it is mandated to. The committee is currently the only one in J&K to have the authorization of the Drug Control authority.

CDSCO registered ethical committee is mandatory for all medical colleges for carrying out medical research. Without the authorization, the medical colleges in J&K have been unable to participate in the multi-center trials of drugs and vaccines currently going on in India.

A senior faculty member in GMC Srinagar said that no medical college in J&K

could become a site for ICMR’s Convalescent Plasma Therapy trials carried out by Indian Council of Medical Research across sites in India.

He said, many drugs, currently being explored for COVID19 were also not available to patients free of cost in J&K as no medical college was able to participate in the trials. He said even at SKIMS, an international study could not be carried forward as the Institute did not have a registered ethical committee.

Prof Samia Rashid, principal GMC Srinagar said the approval of the ethical committee was a major step towards improving medical research as well as patient care in J&K. “Other institutes and medical colleges can also benefit from his approval,” she said.

The approval paves way for clinical trials of drugs and vaccines that may be in the pipeline and that may benefit patients without any cost to them, she said.