The Maharashtra Food and Drugs Administration (FDA) has formally informed the state government about its serious objections to the formation of Central Drug Authority and handing over the state drug regulatory functions including licensing powers to the proposed Central body.
In response to the official query from the state Medical Education and Drugs (MED) department about its views on CDA, the FDA averred that the current drug control system in the state is effective with a well built infrastructure and the central government should entrust the regulatory duty in Maharashtra to the state drug department only.
The FDA officials sent their response and suggestions to the MED department in the middle of November. The drug administration's expression of disapproval to CDA would be intimated to the central government by the state MED department to the Union Health Ministry, said the FDA sources.
The state drug control department also suggested that the Central government should strengthen the state FDA to make it more effective instead of imposing a new central authority which has comparatively very few staff strength and infrastructure facilities. The FDA's current facilities, including the drug testing laboratories, could be increased to conduct more number of tests and inspections if the government extends financial assistance.
One of the main agenda of CDA is to bring an end to the problem of spurious drugs by co-ordinating drug control machinery in various states in the country. "We are already co-ordinating with drug control departments of other states and the DCGI office. This way of networked functioning can effectively prevent spurious drugs prevalence in the state," maintained a senior FDA official.
The state drug control department is currently testing 8500 drug samples in its two laboratories, which is more than 25 per cent of tests conducted all over the country. If the government helps to expand the capacity or to set up new labs, the department could perform more tests, added the official.
Currently, the state FDA is issuing manufacturing licenses through seven joint commissioners, appointed in various parts of the state, and sales license through 32 assistant drug controllers in 32 districts of Maharashtra. Around 28 drug inspectors are assigned in Mumbai alone while there are a total of 100 drug inspectors to monitor the pharmaceutical and pharmacy activities in the state.
Apart from this, the Maharashtra Public Service Commission is proceeding with papers to appoint 60 more inspectors in the state and the vacancies will be filled within a few months. The current staff strength of DCGI's West Zone office consists of less than five drug inspectors and they are in charge of five states in west zone. State FDA officials feel that the whole state drug administration would collapse if it is handed over to the CDA.