The Department of Pharmaceuticals (DoP) under the chemicals and fertilisers ministry is likely to seek curbs on foreign direct investments (FDI) in vaccine producers.
The department’s views will be shared with the expert committee that will be set up to analyse the negative impact of FDI in the sector due to the automatic approval route, a senior government official in the department said.
The government has recently proposed restrictions on automatic FDI approvals in some sectors including airports, seaports, pharmaceuticals, petroleum refining and gas pipelines, citing “sensitivity to national security”.
It has proposed to keep FDI in the pharma sector on the automatic approval route as long as the stake acquired is up to 49%. Currently, 100% of investments are through automatic route subject to maximum investments of Rs 600 crore.
“We do not want to be in a situation when vaccines for epidemic like H1N1 flu would be completely in the hand of foreign players … that can be very risky,” the government official said on condition of anonymity.
Several Indian drug firms are looking to sell stakes to foreign drug majors to raise funds for their expansion and research and development activities. Global pharma giant GlaxoSmithKline’s chief Andrew Witty said on Tuesday that they are looking to acquire stake in Indian firms, especially to manufacture generic medicines.
“Despite the restrictions, we will do everything possible to ease funding so that more innovative drugs can be produced in the country itself,” the official added.
Recently, the Drug Controller General of India (DCGI) expressed concerns on the technology used by Cadila Pharma, a Gujarat-based company’s to manufacture H1N1 flu vaccines. Cadila has a joint venture with US-based drug firm Novavax, called CPL Biologicals, for developing and commercialising vaccines based on VLP technology.
The pharma department is looking to put in a mechanism to promote Indian firms to expand on their own locally to keep prices of medicines and vaccines in check. However, no definite plans have been drafted to promote the sector. Even the new pharma policy is on the backburner as drug firms are opposing it.
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