Delay in import, quality testing push back Sputnik V's commercial rollout in India

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 vaccine in the country, 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 into 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 recognized by the WHO and therefore its every imported batch needs to go through rigorous quality testing in the country, which may take up to a week.  

The vaccine has been imported in India by the Hyderabad-based drug maker Dr Reddy’s which has the sole distribution rights for the first 250 million doses of the vaccine as per its agreement with Russian sovereign fund RDIF. 

The liquid form of this vaccine, which has shown the efficacy of over 90% in preventing Covid, has to be stored at -18-degree Celcius, which makes its storage somewhat logistically challenging. The freeze-dried form of Sputnik V, however, can be kept at 2-8 degree celsius. 

After the vaccine arrived on Indian soil 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 very limited quantities where a few hundred doses have been administered in selected private hospitals. 

These cities are Vizag, Bengaluru, Mumbai, Kolkata, Delhi, Chennai, Miryalaguda, Vijayawada, Baddi, Kolhapur, Kochi, Raipur, Chandigarh, Pune, Nagpur, Nashik, Coimbatore, Ranchi, Jaipur, Lucknow, and Patna. 

By the end of this final leg of the pilot phase, the company is aiming to reach 28 cities in total 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 that the pilot phase has allowed it to test the cold storage arrangements of -18 degree C temperature 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,” it said. 

The company however conceded that there has been a “slight postponement in the timeline of the commercial launch due to dependency on imported consignments, and quality testing in India”. 

The firm, however, refused to divulge the exact number of doses administered in India so far. CoWIN dashboard, maintained by the Union Health Ministry, also does not show this figure.

In an affidavit filed in the Supreme Court, the Centre had said that 10 crore doses of the Sputnik vaccine will be available in India by the year-end after being produced locally.