India: Raise in regulatory fee for imported Pharma products

October 25, 2018


The development of innovative skills in the technology have led to the betterment of human life in numerous forms. Significant impact has been created by the extensive contributions made in the field of healthcare and medicine. Achievements in the area of biotechnology, pharmaceuticals, information technology, physics, chemistry has led to the development of medical procedures and devices, which have proved to be life transforming. Era of growth can be analysed from the availability of advanced drugs, high quality equipment, suitable diagnostics, robotic surgeries, etc.

Pharmacy market in India

With the increase in awareness and better access to medical facilities, the Indian market has seen an elevation in the demand of pharmaceutical products. With the diversity of products ranging from locally manufactured medications to those imported, the Indian pharmaceutical market has grown by leaps and bounds.

Legal monitoring

The legal regime of the Drugs and Cosmetics Act, 1940 under the authority of Central Drugs Standard Control Organisation (hereinafter referred to as “CDSCO”) is administering the commercialization of drugs and medical devices. Therefore, all pharmaceutical products prevalent in the Indian markets have received approval from the CDSCO.

Import of pharmaceuticals

The trade of pharmaceutical products allows the transfer of essential medications across the international borders thereby saving lives of millions of people. The import of such medicines requires authorization from the CDSCO in the form of licenses and registration certificates which ensure that the products comply with the expected standards and norms in respect of their composition.

Hike for imported products

In so mush so that it is beneficial for the import of medicinal products in India for the purposes healthcare, the Government is often confronted with the challenge for encouraging the output generation capacity of India. With a view to control the rampant import of foreign products in this domain, the Government is formulating schemes whereby the importers of foreign drugs would be required to pay upto 5 times more to register such products.[1] Also, the overseas exporters would be required to get their manufacturing set ups audited by an Indian regulator.

This move of the Government aims to increase the domestic production levels in terms of pharmaceutical products thus making the Indian regulator at par with the other world regulators.

For the industry gaining popularity at an accelerated pace, the Government is devising strategies to ascertain that India maintains its pace with the other competitors in the global market enabling it to be an independent manufacturing hub in order to reinforce its economic structure.


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