Hyderabad: The Union government’s proposal to create a Central Drugs Authority that will regulate and monitor the functioning of pharmaceutical companies has run into opposition from the drug departments of state governments, which believe the move will limit their own role.
The government’s move to create CDA—modelled on the Food and Drugs Administration of the US—will expand the powers of the current pharmaceuticals regulator, Drug Controller General of India or DCGI, and set up departments to monitor clinical trials, medical devices, vaccine and other drugs-related businesses. The CDA, awaiting parliamentary nod, will function under the ministry of health and family welfare.
The All India Drugs Control Officers Confederation or AIDCOC, a body of drugs officers representing state drug departments, and the heads of administration in states that have an active manufacturing industry, are opposing the move.
“The confederation made a representation during mid-February asking Anbumani Ramadoss, the Union minister for health and family welfare, to drop the proposal of taking over of manufacturing licensing power from the state drugs departments by the Centre,” Ravi Uday Bhaskar, secretary general of AIDCOC, said.
The Central government plans to vest licensing powers for manufacturing units with CDA to usher in uniform standards for such approvals. Manufacturing applications of drug companies, when rejected by one state, have in the past successfully tried and received approval from another state. A phased five-year transition from the present system to a completely central licensing of drug-manufacturing units has been proposed.
M. Venkateshwarlu, Drug Controller General of India, said: “The objective of centralizing the manufacturing licensing system is to bring in uniformity in the country. Each state has its own yardstick at present and the effort is to develop a single yardstick for the entire country.”
But a Maharasthra state government official said the answer lay in making the process and standards uniform. “States can work out a model wherein they can bring in uniformity in compliance, stricter monitoring of rules and train manpower,” said Amitabh Chandra, commissioner of the Food and Drugs Administration of the state. “CDA should monitor the system and leave the licensing responsibility to respective states. CDA will find it difficult as its manpower needs could be high.”
“Centralized licensing may delay the disposal of applications, particularly those relating to exports, which are time-bound. This will concern manufacturers the most,” said Pramod Jain, director at the Directorate of Food and Drugs Administration, Goa. State drug department officials in West Bengal and Andhra Pradesh said they support this view.
Regulation of India’s drugs industry, ranked fourth in terms of volume of drugs production and No. 13 in value, has been a tedious process with authorities having little control over quality of regulation.
As part of larger reforms in the sector, the Central government proposed in the draft National Pharmaceutical Policy last year that an independent and autonomous CDA be constituted. According to the proposal, CDA will be headed by the DCGI, a technical expert in the rank of additional secretary to the government.
In the long term, the government has proposed merging the National Pharmaceutical Pricing Authority, the drugs pricing regulator, into the CDA to form a National Authority on Drugs and Therapeutics, which will be an integrated regulatory authority in the country.