The fragmented India pharma market needs a larger regulatory workforce, better drug testing laboratories including on-the spot analysis of medicines picked up by inspectors to report faster assessment of quality, noted Dr Rao VSV Vadlamudi, president, The Indian Pharmaceutical Association (IPA).
Now that the government of India in its recent budget has allocated Rs.1,750 crore to strengthen the regulatory machinery, we anticipate a positive outcome in the drug inspection methods and a robust enforcement mechanism in place, Dr. Vadlamudi told Pharmabiz in a telecon.
Funding from the government to the tune of Rs.1,750 crore has created a hope on the horizon. This funding was necessary and now we can look forward better infrastructure, increased manpower in drug administration both at the centre and state governments. Out of the Rs.1,750 crore, Rs.900 crore is for the CDSCO and the remaining Rs.850 crore is for the state regulatory departments. “With these funds, we are optimistic about the creation of a stronger regulatory system,” he said.
In fact, IPA had in its recommendation to the government prior to the Union Budget 2014-1015 pressed for strong regulatory system with adequate manpower and advanced infrastructure. “We do believe that earmarking huge funds for the strengthening of the regulatory systems could be an outcome of our recommendations,” noted Dr Vadlamudi.
The current issue in the pharmaceutical sector is the fragmented existence of pharma manufacturers scattered across the country. There are not just Indian multinational pharma majors but also small-medium enterprises engaged in the production of life saving drugs, generics and active pharmaceutical ingredients making the country as the fourth largest in volume and 14th largest in terms of value. It is estimated that there are over 2,50,000 drug brands in the country. “This creates a difficult and challenging task to the regulatory authority, said Dr Vadlamudi adding that the enforcement personnel are inadequate and need to be further augmented”.
The presence of qualified regulatory team at the Centre and the State would only ensure the required coordination. An ideal situation would be to enhance the human resources in the regulatory departments for speedy test of drugs and dissemination of reports. Going by the advanced test equipment, the regulatory authority should introduce methods of on-the-spot testing of drugs by its inspectors at the pharmacy outlets to confirm the quality of the drugs and those that are suspected to be sub-standard could be sent in for further assessment. This would save considerable time, said Dr Vadlamudi.