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Regulatory Requirements for Registration of Pharmaceutical to Gain Market Access in India.

Suresh S, SB Puranik, Phatru Patel

The value of the global pharmaceutical market is expected to grow at 5 percent CAGR, to be USD 1 trillion in 2014 according to Urch publishing. The pharmaceutical industry is one of the highly regulated industries, to protect the health and well-being of the public. In the present scenario, India have stringent regulatory requirements for approval of a new drug. The single regulatory approach for marketing authorization application (MAA) of a new drug product belonging to various categories of drugs (NCE, Biologicals, Controlled Drugs etc.) is utmost difficult. Therefore, the knowledge of precise and detailed regulatory requirements for MAA of different categories of drugs should be known to establish a suitable regulatory strategy. This article focuses on the drug approval process from regulatory authorities for different categories of pharma products. Finally, there needs to be a reaffirmation and fine balance between the tenacities of gaining market access of pharmaceuticals is to protect the public health and facilitate healthy growth of pharmaceutical manufacturers. Pharmaceutical product approval process should be seen as a critical step in ensuring access to safe and effective drugs.