‘There should be a separate agency exclusively for drug research on the lines of DBT’

Intellectual Property Rights (IPR) in India enjoy a very good status altough it has been criticised a lot by the US officials. The US pharmaceutical companies have demanded that India should amend its patent laws by eradicating Section 3d altogether. Also, pressure is being created on Indian Health Ministry to not consider drugs for compulsory licensing.

Through the decision of Gleevec case the Supreme Court and the Indian Government has clearly indicated that pharma companies cannot take Indian patent laws for granted. The public health advocates, charitable groups and NGO’s appreciate the decision.

Also, the Indian Supreme Court and IPAB takes decisions not only from industry perspective but also keeping in mind poor Indian patients. It is significant to note that many poor patients of underdeveloped nations rely on India for the supply of cheaper versions of latest treatments for HIV and other diseases.

On the contrary, after the decision, the pharma companies would not be very comfortable in launching new drugs in India. They have become more concerned about the environment for innovation and investment in India. The general view point of the pharma companies is that the patent rulings in India have favoured generic producers.

If the Government continues to keep a unaffected image towards MNCs as seen with Gleevec and Nexavar (compulsory licensing) case, we are definitely going to lose intellectual uprgadation which these MNCs may provide by opening up their Drug Research Programme in India.

Incentives to spur R&D; and benefits of excise free zones

Certain zones have already been created in some parts of the country in the past. As a result there has been an enormous  socio economic development of those regions for eg. Baddi, Bhiwadi etc. More such tax free zones are required in the Northeastern states but the Government should keep in mind that they are in close proximity to some good research institution. India has no dearth of manpower and if policies of the Government are to promote production and export of drugs then there is no reason that we cannot think that we will be the number one supplier of generic drugs to the world market. But on the same side, we must ensure the quality of our products. In order to ensure the quality, strict checks are required. Unfortunately, we don’t have the required number of staff with our drug control department to ensure this. Despite of the huge initiative given to the pharma companies to boost up their research facilities, India has failed to develop a good research environment in this sector. I believe the sole reason is lack of quality of higher education, as a result we are not generating good researchers in drug research. A complete overhaul is required in this. Industrial research should go hand-in-hand with institutional research and incentives should be given to such industrial-institutional collaborative programmes. Furthermore, there should be a separate agency exclusively for drug research on the line of DBT or DST, ICMR, CSIR where disbursement of funds will be processed to the institutions involved in pharma education exclusively.

Clinical trials

The clinical trials industry, which analysts have previously dubbed as the ‘sunshine sector’ and perceived as a potentially upcoming segment, is at a crossroads today. Among its many challenges is the lack of a standardised and balanced regulatory structure, along with an increasing number of datacompromise allegations. Clinical-trial approvals have faced significant delays, which has led to a scenario where the very future of the industry is now uncertain.

Various factors contribute to this uncertainty. For instance, the Drug Controller General (India) (DCGI) usually takes 12 to 16 weeks to approve trials as against six to eight weeks in the US. The industry is also becoming progressively competitive, with countries such as China, Korea and Singapore emerging as fierce competitors. Meanwhile, MNCs are reportedly lowering their budgets while focusing on bringing drugs to the market quickly. Manufacturing is becoming the key focus of most companies, and CROs (especially CMOs) could benefit from this development. The decline in clinical trials in the US has led to an increase in trials across emerging countries.

– Dr Arun Garg, General Secretary, Indian Pharmacy Graduates’ Association