Indian Vaccine Exports May Halt If Central Authority Does Not Comply With GMP Norms
This article was originally published in PharmAsia News
Executive Summary
MUMBAI - Large vaccine manufacturers in India may not be able to export their key products for long, nor can they cater to domestic demand, as the apex testing laboratory for vaccines - the Central Research Institute - has been de-recognized from doing such tests by the Drug Controller General of India.
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MUMBAI - Large vaccine manufacturers in India may not be able to export their key products for long, nor can they cater to domestic demand, as the apex testing laboratory for vaccines - the Central Research Institute - has been de-recognized from doing such tests by the Drug Controller General of India. As a result, vaccine producers like Bharat Biotech and Panacea Biotech may not be able to get their batches tested for exports, a senior government source told PharmAsia News. Sources in the industry said that since last year the World Health Organization has mounted pressure on the DCGI to force the CRI to implement good manufacturing practices at its labs. These include sweeping changes in documentation, record keeping, infrastructure for vaccine testing, training manpower and streamlining other practices and protocols. In addition to testing, CRI also manufactures key preventive vaccines for DPT, yellow fever and typhoid. While the Indian government has approved funds to comply with the required changes in GMP, there is already a temporary shortage of DPT, BCG and tetanus vaccines for hospital supplies, the government official stated. This shortage may last for a few more months until testing rights at CRI, Kasauli is restored. The government may soon go for an international bidding process for supply of these vaccines to cater to the domestic demand at least in the short term, the health ministry official told PharmAsia News on condition of anonymity. "Vaccine manufacturers are trying to sit together with the government to expedite the compliance issues faster so that exports and supplies to domestic health institutions do not get held up for a longer period," said Krishna Ella, chairman of Bharat Biotech. Indian companies like Bharat Biotech, Panacea Biotech, Serum Institute of India and Shantha Biotech are among the largest vaccine manufacturers. Direct exports by government labs to various WHO programs are also significantly high. The total vaccine export from India is roughly $250 million every year. - Vikas Dandekar ([email protected]) |