The Indian pharmaceutical market is highly competitive and remains dominated by low priced, domestically-
The need to maintain low prices for essential medicines has been addressed in the government’s draft National Pharmaceutical Pricing Policy (NPPP), released in 2011. The proposed NPPP focuses on the National List of Essential Medicines (NLEM), which is periodically revised. The headline major change is a move from the principle of cost-based pricing to a market-based pricing model. The Department of Pharmaceuticals argues that market-based pricing would result in more transparent and fair pricing, as well as increasing competition in the marketplace. Price regulation will encompass all drugs listed in the NLEM, as well as formulations containing combinations of drugs listed in the NLEM; this will include combinations comprising listed drugs and unlisted drugs. If the NPPP is implemented, around 60% of the drugs currently available in India will come under price control.
The Indian pharmaceutical industry (http://www.bharatbook.com) is responsible for around 10% of world pharmaceutical production. Over the last few years, a number of Indian pharmaceutical companies have been targeted for foreign acquisition. Concerns have been raised that this trend could adversely affect generic drug prices in India. The Ministry of Health wants safeguards built into the Foreign Direct Investment process amid fears that continued foreign acquisitions will adversely affect the domestic industry and push prices up, thereby potentially undermining the government’s efforts to make generic drugs affordable. This could lead to essential medicines becoming more expensive and adversely affecting public health programmes.
India has published new Guidelines on Similar Biologics. The Guidelines were prepared by the Central Drugs Standard Control Organisation (CDSCO) and the Department of Biotechnology (DBT) and lay down the regulatory pathway for a similar biologic claiming to be similar to an already authorised reference biologic.
The reports provide:
Market size and trends impacting the development of the market.
Five-year projections for market indicators such as health spending.
Regulations on drug applications & approvals, pricing & reimbursement as well as wholesaling and retail.
Specialised intelligence on generics and biological medicines.
Foreign and local company profiles
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