‘‘Let this be the tipping point, but in a way that is to the benefit of all stakeholders’’

A year ago the impending Drug Prices Control Order (DPCO) was a key topic for debate. One year down the line the new DPCO has been announced and continues to be a hot topic for debate! And it is not just the DPCO but the environment in which the pharma industry operates in India at present leaves much to be desired. The main issues here seem to be lack of transparency, a limited understanding surrounding clinical trials (CTs) and intellectual property rights, and finally, a misplaced belief of what is good and right for the ultimate beneficiary – the patient.

Let us look at each of these issues as they stand today

The new DPCO has been announced but the complexities of its implementation were not fully thought through. The logistics involved in recalling and stickering drugs is a complicated manoeuvre not to mention the challenges related to medicines that have special storage conditions. We are now well past the original deadline of 45 days but there is as yet no clarity. Some companies and associations have gone to Court. All stakeholders need to come together to ensure that the patient continues to stay well. India is a recent entrant to CTs. For a long time we were content consuming medicines that had never been tested on India’s genetic pool. Now we have global CTs taking place in the country but a lot of misguided information and policies that are not fully formulated. The Ministry of Health needs to ensure speedy formation of the Central Drug Authority. With that, industry hopes that the regulatory environment for not just CTs but also drugs and medical devices will be greatly improved.

Patient safety is of paramount importance

We, as an industry, are more than willing to walk the talk to ensure that we comply with the regulations in letter and spirit. Global companies have norms that they must comply with, with regard to pharmacovigilance, and this needs to be fully in place here as well for the pharma industry as a whole. It is important to have good pharmacovigilance so that safety profiles for drugs used on Indians are enhanced. As always, it is all about the interest of the patient.

Intellectual property rights continue to be a hot topic for debate – there are what are seen as patient rights on the one hand and the ability to continue to invest in research and development on the other hand, all to the benefit of the patient in the long term. Recent cases are not suggestive of an environment that fosters innovation no matter which way you look at it. Patents are granted then revoked. Patents are granted then violated with impunity. Patents are not granted citing specious arguments. Perhaps the time is right for not only raising awareness by collaborating with patent offices in other parts of the world but the time has also come to set up fast track courts to decide patent cases. Clearly for patents to be of any value to the innovator time is of the essence.

We live in different times. The Indian pharma industry has come a long way. Let this be the tipping point but in a way that is to the benefit of all stakeholders keeping in mind the interest of the patient and the need to challenge unmet medical needs. Let the debate end.

– Ranjit Shahani, President OPPI and Vice Chairman and Managing Director, Novartis India