Indian pharma eyes pride of place, regulation Achilles heel

New Delhi : India is on track to cement its position next year as a source of safe, effective and quality medicines at affordable prices, but a "growing trust deficit" with the government and regulatory headwinds can pose a serious roadblock to this journey. The USD 32-billion generic-driven Indian pharma industry is eyeing a sea of opportunities as global demand for safe and quality drugs rises, especially in developed economies such as the US, the EU and Japan. Apart from the trust deficit that was in full display in the year passing by, compliance with regulatory norms, particularly with USFDA, continues to be the proverbial Achilles heel for home-grown companies.

"The sector will continue to grow and become a major player in the world market as a source of safe, effective, quality medicines at affordable prices," Indian Pharmaceutical Alliance (IPA) Secretary General Dilip G Shah told .

His optimism stems from "greater acceptance of Indian generics as safe and effective medicines".

Demographic pressure in the developed countries has made them limit their health expenditure, Shah said.

Industry body Organisation of Pharmaceutical Producers of India (OPPI) has hailed the government's move to introduce regulatory amendments to relax clinical trial guidelines and upgrade rules for good manufacturing practices (GMPs).

These are "in the interest of patient safety and help put India on the global research map", OPPI DG Kanchana T K said.

"The sector faces two major issues in the domestic market, viz. growing trust deficit between the industry and the government and breakdown of meaningful dialogue between the two," Shah remarked.

Asked about the challenges facing the industry, he said "(it's) the government's suo motu actions that could compromise India's IPR regime and hurt generics and absence of shared vision".

While future looks rosy albeit with challenges, a lookback at 2016 is a pointer to the bitter pills that the industry swallowed during the year.

In March, the government banned 344 fixed dose combination (FDC) drugs, making pharma firms see red, which termed the decision "arbitrary, unfair and a letdown" and approached the Delhi High Court.

"Maximum litigation with pricing and drug regulators is the high point of 2016," Shah said when asked to sum up the events of the year. "In the last one year, over 400 companies had to go to courts to resolve their grievances relating to pricing and drug regulatory decisions."

In a relief to the industry, the high court set aside the government's decision, saying the step was taken in a "haphazard manner" without consulting statutory bodies as mandated under the law and such drugs cannot be banned for any reason other than posing risk to consumers or having no therapeutic value or justification.

The temporary ban impacted sales of many companies though.