The major factor that impedes the efforts for bringing a uniform drug administration in the country is the vested interests of state drug control departments, says Ashwini Kumar, the drug controller general of India. " The states are unnecessarily creating panic among the industry about the proposed central licensing system. This panic among the industry would ultimately result into hampering the best interests of the country to restructure the country's drug regulation for a positive change," he said.
The DCGI, while speaking at the 43rd Annual celebrations of the Indian Drug Manufacturers Association (IDMA), asserted that the existing decentralized drug regulatory system in the country is the main cause for diverse standards of drug licensing and manufacturing in the country. In this context, I must say that the industry is not the only culprit for the wrong doings in the drug sector but the current system of drug administration is also equally responsible," he added.
In the presidential address at the celebration, Yogin Majmudar, president, IDMA, dwelt on the soon emerging product patent in the country. He said, "We have been advocating a balanced Patent Regime, which would on one hand reward genuine innovators and at the same time, minimizes public damage from monopolies. This is possible by way of adequate legal remedies viz., pre and post grant opposition to ensure that only NCEs are granted Product Patent, definition of Patentability being very precise and unambiguous to ensure that 'me-too' drugs do not get Patent protection etc. etc."
Similarly, unrestricted use of Compulsory License provisions as advocated by Doha Declaration, particularly for export to 49 LDCs and other developing countries will also go a long way in ensuring continued availability of low cost medicines to our people as also to those needy across the word. Only last month the Brazilian Government on World AIDS Day announced that, to prevent the financial collapse of its successful public health programme of providing free antiretroviral drugs to HIV/AIDS infected persons would break the patent of several medications. As the Brazilian law permits the government to disregard patents in case of health emergencies such as the HIV/AIDS epidemic, antiretroviral drugs will no longer enjoy patent, he added.
Kiran Mazumdar, CMD, Biocon Ltd was the chief guest and keynote speaker. In her address, she spoke on the topic "Emergence of biopharmaceuticals -addressing unmet medical need". The other speaker at the annual celebration was N H Israni, immediate past president, IDMA. The IDMA awards were presented at the event and the Association released the annual publication 2005.