With the representatives of both multinational pharmaceutical companies and the domestic (generic) companies refusing to dilute their stand on data exclusivity, the inter-ministerial meeting called by the Department of Chemicals and Petrochemicals here recently stressed the need for exploring the possibilities of a 'balanced approach' on data protection for pharmaceuticals.
The balanced approach will not be the result of a consensus among all sections of pharmaceutical industry but will be an option largely acceptable to everybody. The need to respect innovations by Indian companies as well as multinationals without compromising the larger public health interest was highlighted.
The deliberations at the meeting were an indication of the growing support towards the 'balanced approach', which, incidentally has also been advocated by a third section of the industry. The proponents of the 'middle path' are those drug manufacturers who have worked out their future business plans in association with the multinational companies. These companies are looking for increased collaborations with multinational companies at all levels of drug development, manufacturing and marketing. The companies who want to align with the multinationals for their future growth feel that the 'comfort level', the moderate data exclusivity can provide to their foreign partners, is very important for their future business relationships. They feel that the introduction of data exclusivity (non-reliance of innovator's test data clause) can help Indian companies forge better alliances with companies of countries having similar laws in the field of pharma innovation, R& D collaboration and outsourcing. Contract clinical trials, contract R&D and biotechnology R&D would also have significant benefits if the 'data exclusivity' provision is in place, they feel.
While the multinational companies are for all out 'data exclusivity' irrespective of the patent status of the drug, the 'balance approach' suggests curtailing the term of exclusivity within the patent period.
Nicholas Piramal India Limited, a company that has been consistent in its support towards a 'balanced approach' is of the opinion that the introduction of data exclusivity would enhance the trust their foreign partners have in them. "The data protection should be for a period of 5 years starting when the company markets its products in India, or end with patent expiry whichever is earlier. The DCGI should put in a mechanism to protect confidentiality, special provision of data submitted for clinical trials, to be kept confidential by regulator. The rules should be specifically worded to prevent ever greening of patents and one should be certain that patent has been filed in India before data exclusivity is granted." Harinder Sikka, Sr President, Corporate Affairs, Nicholas Piramal India Limited, explained. According to him, the model should be acceptable to both domestic pharmaceutical companies as well as the multinationals.
Interestingly, the policy stand adopted by the Department of Scientific and Industrial Research (DSIR) under the leadership of Dr R A Mashelkar also toes similar line as the 'balanced approach' supported by them is to help promoting R & D and the common man's interest.