In his address to the Organisation of Pharmaceutical Producers of India (OPPI) members at the 37th Annual General Meeting at Mumbai recently, the organisation president Ranjit Shahani spoke on how the pharma industry is dismayed that the new pharmaceutical policy declared by the Union government has been subjected to litigation and resolution now lies with the Supreme Court. The resultant delay has caused serious concern and the uncertainty has affected the expansion plans of business and strategic investments. The thorny issue of Drug Pricing Equalisation Account remains unresolved, he said. Besides, a speedy implementation of Dr. Mashelkar Committee’s recommendations will give some relief in minimizing the impact of the very serious problem of spurious drugs.
Currently the pharmaceutical market is estimated at $ 6 billion, which is expected to grow to $ 25 billion by 2010.
Understanding biological sciences, informatics and computer aided design provide an opportunity to prediction and modeling. This implies that a developing country like India with a superior IT base can leapfrog current approaches and move to a new paradigm in R&D. Similarly biotechnology drugs represent a significant part of the new innovative medicines launched worldwide and India with its rich pool of resources can do well, he said.
India has multiple strengths, which can make it a preferred destination for outsourcing R&D. It ranks third, next to US and Russia in the number of science and engineering students. Around 16 per cent of scientists and researchers working in US are Indians. The biotech global spends on outsourced R&D is estimated at $ 7 billion. The clinical research market in India is around $ 80 million. India has superior benefits in undertaking cost effective clinical trial research. A number of global companies have commenced outsourcing clinical trial research in the country.
OPPI expects several R&D facilitating factors, said Shahni. Acceptance by the government of the benefits of privatization and market liberalization as also rationalization of government controls will drive a degree of speed in R&D efforts. Higher tariff rates and issues like excisability of stickering on imported formulations work as negative factors in attracting R&D investments from global companies. Price controls, which are excessive and administratively rigid also, work as barriers in increasing R&D investment. “However, the domestic market attractiveness and favorable tax policies with fiscal incentives are positive signals to broaden R&D base in India. But the most important incentives relates to IPR. Any country developed or developing without strong and consistent support for IPR will have to struggle to create a domestic R&D base or even attract FDI or technology transfer in the pharmaceutical industry,” said Shahani.
Despite facing lot of acrimony in the countdown to WTO regime from various quarters like NGO’s and other protectionist lobbies against India’s stand on becoming a WTO member, the country will eventually sign in the deal, affirmed Jairam Ramesh, well known economist and economic affairs advisor to the congress party.
Giving his keynote address at the event Ramesh said, “By January 1, 2005, India will be the new member on the WTO block, paving way for product patent regime leaving scope for compulsory licensing and granting a tenure of 20 years on a patent.” Strict enforcement of the WTO regime. He cited the example of China, which despite having become WTO signatory in 2002 did not strictly enforce the rules. A recent survey thereby showed that 25 per cent of drugs manufactured there were spurious.
The key point of focus has to be in enforcement of the country’s regulatory system with upgradation of clinical trials infrastructure.
Wishing the OPPI success in its endeavors, S.S. Dhindsa, Union minister for Chemicals and Fertilisers assured that the Union government has taken several initiatives to facilitate the growth of clinical research in the country, which include exemption from customs duty for material required for clinical trials and exemption from registration for drugs imported for clinical trials. Moreover, a draft amendment had been notified on August 28, 2003 on the Schedule Y of Drugs and Cosmetics Rules has been made and a progressive review is underway, the minister said.