Foreign vaccine purchase tough task

States may face delays in getting approvals from Indian drug regulatory authorities

Hyderabad: The proposal to administer Covid vaccines for all individuals above 18 years could take a longer time than anticipated, as more than 10 States across the country vie with each other to procure vaccines from foreign manufacturers through global tenders.

With Serum Institute (SI) and Bharat Biotech (BB) unable to meet the demand for vaccines and the Centre decentralising vaccine procurement process, many States including Karnataka, Andhra Pradesh, Delhi, Telangana, Uttarakhand, Odisha, Madhya Pradesh, Uttar Pradesh and Rajasthan find themselves pitted against each other in the race to import vaccines.

Apart from TS, other States including AP, Delhi and Karnataka on Tuesday joined the fray and floated global tenders for vaccines. Senior health officials familiar with the process said there is no clear signal or clarity on when the foreign vaccine manufacturers will be able to supply the vaccines. Then there is the issue of whether the global tenders will elicit enthusiastic response from foreign manufacturers, as they already have prior commitments to supply vaccines to other countries.

States looking to procure vaccines from foreign manufactures are also expected to face delays in getting approvals from Indian drug regulatory authorities. At present, Indian regulatory authorities have approved Covishield (SI), Covaxin (BB) and Russian vaccine Sputnik. In case, the regulator authorities insist for data from bridging trials on Indian population, the approvals to administer imported vaccines could take longer.

According to reports from various media sources, Serum Institute (SI) and Bharat Biotech (BB) will be able to produce close to 85 million (8.5 crore) in May and June. Based on the procurement agreements, a majority i.e. half of the vaccine doses will go to the Centre. Individuals States will be left with 20 million (2 crore) and private hospitals another 2 crore of Covid vaccines, which will not be able to meet the requirements.

To address such challenges and ensure quick availability of vaccines, public health specialists and even political leaders have started demanding that the Centre open-up licensing and Intellectual Property Rights (IPR), which will enable other vaccine manufactures, apart from SI and BB, to manufacture vaccines.

However, vaccine manufacturers will face difficulties even if licensing and IPR are opened-up because manufacturing generic drugs is different from vaccines. Vaccine manufacturers will need access to the entire technology, equipment, trained manpower and the exact manufacturing process that has gone into designing and testing the vaccine. Top officials from other Indian manufacturing companies, in their interactions with media, have pointed out that even minor changes in the entire process could lead to failure of the vaccines.

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