The government will invest Rs 3,000 crore over the next three years in the pharma sector to strengthen the drug regulatory system in the country.
"Strengthening the regulatory system is on our agenda. Indian regulators are aware that there is a gap in the regulatory system which needs to be filled up. India has a dual system of regulation for the states and the Centre. Our work is to strengthen the regulatory system both at the Centre and state levels. The 12th FYP will see an investment of $0.5 billion or about Rs 3,000 crore from the government which will also be used to strengthen the state-level regulatory bodies. Money will not be a constraint as the government is ready to invest further. But this should be done gradually. About 40% investments will be made to strengthen the states whereas the rest will be for Centre," G N Singh, drugs controller general of India, told media on the sidelines of the International Exhibition for Pharma and Healthcare (iPHEX 2014).
The government is planning to have more new drug testing laboratories as well as labs at the ports. Apart from 31 existing state labs, there will be 10 more laboratories in the country to ensure that pharma export shipments meet global quality standards.
Sudhanshu Pandey, joint secretary, department of commerce, ministry of commerce and industries, said, "The investments are largely in three sectors: infrastructure, human resource and for capacity building."
Along with this, the focus is also on increasing the human resource strength. At the Centre, the count of drug regulators will be increased to 1,000 from current 500 in the next 2-3 years whereas, at the state-level, the count will be doubled to 3,000.
S Eswara Reddy, deputy drugs controller general of India, said, "Around Rs 1,800 crore will be provided to strengthen the Central Drugs Standard Control Organisation (CDSCO) and the remaining Rs 1,200 crore will be for strengthening the states. Out of the Rs 1,800 crore, around Rs 600 crore is reserved for infrastructure like civil construction, equipments and other parts. Another Rs 184 crore is going towards e-governance because this is one of the toughest system we have identified to strengthen the drug regulatory system. We are also going to have a National Drug Regulatory Training Academy in Hyderabad."
To enhance patient safety, the government plans to increase adverse drug reaction monitoring centres to 350 from 150 at present which will bring all the medical colleges under its umbrella.