Pressure from International regulators on the Indian formulators is viewed by Indian industry and the government as a long term strategy by the developed nations to contain India’s popularity in the global markets. Such a stand can restrict leading Indian manufacturers to take advantage of the post off patent regime which may open up huge market potential for Indian generic makers.

According to Ravi Uday Bhaskar, Secretary General, AIDCOC, it is ironic on the part of international regulators like US FDA, EU and even regulators from small countries like Vietnam and Sri Lanka talking quality, efficacy, data integrity and crying foul about formulation manufacturing units in India when Indian industry is well placed in comparison to its position a decade ago.

“The international regulators becoming strict against Indian formulation companies and not talking about the API units, speaks volumes that they are purely driven by the strong business lobby within their country. They have not pointed against the Indian API makers because majority of them depend on the low priced APIs manufactured in India for their formulation units abroad. This is the right time that we should also unite and give no scope for the international regulators to point finger at our industry or our regulatory system,” said, Bhaskar, advocating that the Industry and regulators should work hand in hand to make Indian pharam sector more robust.

The time has come for the Indian policy makers, the regulators and the pharam industry to work together and adapt to the global regulatory changes and incorporate the same within country's systems from time to time and give not much scope for the international regulators to point any figure against our industry.

There is a strong feeling in the industry and the Indian government that the international regulators are deliberately targeting the Indian players to exert pressure and malign the Indian image in the global market in the event of majority of block buster drugs getting off patented by end of 2015.

As already Indian industry has proved its capabilities and robustness in the international markets in delivering highest quality generic medicines at much more affordable prices than their western counter parts, the Indian companies are equally racing with the western companies to capture the generic market opportunities that is going to open up huge markets during the off patent period. Already leading Indian players are filing new drug applications and registering their products throughout the globe to expand their business in to the newer global markets.

Similar to capture the Indian markets, many leading international companies like Mylan, Abbot, GSK etc are acquiring smaller companies for expanding their business in the country. “Not many international companies have set up their own plants but have acquired Indian medium and small companies and are planning to take advantage of India’s low cost environment and skilled good English speaking working force in the country,” added Bhaskar.

So it’s time for our industry and the regulators to chalk out ways and means to see that they not only comply with international standards but at the same time should also deliver their responsibility to serve the domestic healthcare in the country.