NEW DELHI: Dependency on imported consignments and mandatory quality testing of every batch in India has pushed back the commercial availability of the Russian Covid-19 vaccine Sputnik V, over six weeks after it was soft launched here.
Recently, India’s apex drug regulator waived the requirement of conducting bridging clinical trials and mandatory testing of every batch of Covid vaccine by the Central Drugs Laboratory, Kasauli, for foreign-made vaccines to ease their entry in the country.
However, the relaxed norms apply only to vaccines approved by the US Food and Drug Administration, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, UK, Pharmaceuticals and Medical Devices Agency, Japan, or which are listed in WHO Emergency Use Listing.
Sputnik V does not make the cut as it is yet to be recognised by the WHO and every imported batch of the vaccine needs to go quality testing in the country, which may take a week.
The vaccine has been imported in India by the Hyderabad-based Dr Reddy’s which has sole distribution rights for the first 250 million doses, as per its agreement with Russian sovereign fund RDIF. Liquid form of this vaccine, which has shown efficacy of over 90% in preventing Covid-19, has to be stored at -18 degree Celcius, which makes it logistically challenging. The freeze-dried form of Sputnik V, can be kept at 2-8 degrees.
After the vaccine arrived in India on May 1, its first dose was administered in a private hospital in Hyderabad on May 14 and has since reached 21 more cities in limited quantities where a few hundred doses have been administered in select private hospitals.
By the end of this final leg of the pilot phase, the company is aiming to reach 28 cities after two of the company’s consignments comprising nearly 3 lakh doses reached India but the third lot — slated to arrive by June-end — is delayed.
A Dr Reddy’s spokesperson said the pilot phase has allowed it to test the cold storage arrangements of -18 degree C in these cities, CoWIN integration, track-and-trace and other logistical arrangements ahead of the commercial launch.
“Adequate numbers of cold chain units are being deployed, and the last mile cold chain arrangement is being validated at every partner hospital to ensure seamless storage and handling of the vaccine.” The company, however, conceded there has been a “slight postponement in the timeline of the commercial launch.”