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Aftermath of the Drug Price Control Order 2013
The Drugs (Prices Control) Order, 2013 announced on 15th May 2013 by the Department of Pharmaceuticals, in an attempt to avail drugs at an affordable price to the Indian population has created a stir in the Pharma Industry. Pharma Bio World in an exclusive interview with Dr Gopakumar Nair, Founder, Gopakumar Nair Associates, explores the two sides of this new policy. Gopakumar Nair Associates is a leading legal consultancy firm advising to the biotechnology, chemical, pharma and healthcare industries.

Do you support the DPCO 2013 or do you see it as a bad move for the Pharma Industry? Please share your views (pros and cons) about this new Policy with us.
Indian Pharma Industry has waited long enough for a new policy. The policies of seventies, eighties and nineties were relatively one-sided. The Government of India had nurtured the Indian Pharma through infancy and the teens. Having reached adulthood, the Government has rightly stressed on the Indian policy of "affordable access" for the masses on a larger canvas than anticancer and anti-HIV drugs. This time, the 2013 Drug Policy is not one sided, having the Courts- including the Supreme Court - massively being pursued (and reasonably succeeded) by the NGOs of the country.

The Department of Pharmaceuticals did a commendable job under stress and excessive pressures from the NGOs both directly and through the Apex Court. Kudos to the Policy Makers. That said, the policy needs a few corrections for practical implementation, without undue avoidable litigations. The faulty interpretation and implementation of DEPA of yesteryears have led to very unreasonable demands on the Industry.

Impractical conditionalities may leave much room for discretionary actions leading to protracted and multi-locational litigations. Indian Pharma is a survivor. It survived the WTO/TRIPs challenges from outside. This challenge from inside should also be taken head on by India Pharma. Any law which applies to all should be no problem for the Pharma Entrepreneur, who will ride every wave and move on.

However, it will be sad, if the erstwhile, 1995 Policy and its provisions are officially not declared as closed in view of the new 2013 Policy. Operating and managing the 2013 Policy with all the confusingly conflicting provisions of 1995 policy will be unfair to the Industry.

According to the new Price Order the price of the bulk drugs is not going to be altered although there is going to be a fall in the cost of formulations. What will you advise the pharma companies so as to cope up with this change to sustain in the industry?
The exclusion of Bulk Drugs from pricing was long overdue especially in view of the declining trend in Indian API/Bulk Drug manufacturing operations. In view of built-in provisions and potential exemptions, there is no need for concern on this score.

Would you suggest manufacturing outsourcing as an option in this situation? If yes, how does this help?
Manufacturing outsourcing is no new phenomenon for India. The DPCO 2013 would not/need not be a catalyst for increased manufacturing outsourcing. This trend in Industry is on the ascend any way.

Do you think the new Pricing policy will have adverse effects on the quality of the products manufactured by a company?
No. Indian Pharma Industry is the most controlled, regulated industry in the world. Soon, the licences to be obtained by Indian Pharma will exceed 100, at a time when we say the "licence-raj" is a thing of the of past. More over, Indian Pharma is substantially selfregulated. On the contrary, the new DPCO bringing down the disparities in range of prices also acts adversely against spurious players, if any (mostly all unlicenced).

Will you suggest discontinuing the mfg of the scheduled drug formulations/ introducing manufacturing of formulations of unscheduled drugs or none?
Discontinuing manufacturing of scheduled drug formulations are in contravention of DPCO 2013. There is no bar on introducing unscheduled formulations. I am sure, the Indian Pharma would consider non-contravening legally valid options for working around to survive economically.

Since the DPCO 2013 strives to incentivise indigenous R&D, do you see this as a good opportunity for R&D to survive the competition or is this move going to hinder the further growth of the Indian Pharmaceutical Industry?
Indian Pharma Industry needs to undertake research for patenting and approval for a ‘new drug’ (which can be a new product, new process or novel drug delivery system) from the Drug Controller General (India). A new drug is exempted from the DPCO 2013 for five years from the day of its introduction in the market. It is hoped that Indian Pharma companies will make full use of this golden opportunity throug hindigenous research and innovation which will add to the growth of this Industry.

Do you think the big Indian pharma players will look at India as a potential market or will they now target the foreign market to draw profits?
Big Indian Pharma cannot and will not ignore Indian market. They may strategise for overseas operations for sustaining their ROI, but will continue to cater to Indian market for all the right reasons.

Will this step taken up by the Indian Government be successful in ensuring the easy availability of medicines to the weaker section of the society? If not, what else needs to be done in your opinion in order to make it a success?
To make this initiative of 2013 Drug Policy a success, the Government will need to treat the transitionary provisions softly and allow the policy to get implemented, with genuine exceptions. The benefits are bound to reach the public at large eventually, improving affordable access, to the larger needy community.