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The government is planning a Rs 1,750-crore revamp of the drug regulatory apparatus in the country to ensure that there is at least one functional drug testing laboratory in every state. Currently, 10 states have no testing laboratory of their own. These include West bengal, which has a referral laboratory, but no place where drug samples lifted by state drug inspectors can be tested.
According to the MoU the Health Ministry is signing with states for setting up or revamping laboratories, the Indian pharmaceutical industry is growing at the rate of 10 to 12 per cent per annum. It is the third largest in the world by volume and 10th by value. The total size of the industry is about Rs 2 lakh crore, out of which exports account for nearly 55 per cent.
However drug regulation in many states is poor. Delhi, for example, neither has its own testing laboratory nor a state drug controller for nearly a decade now. Uttar Pradesh has a laboratory in Lucknow but that is not functional. Bihar and the northeastern states do not have laboratories of their own. Many of these states send the samples lifted by their drug inspectors to the Centre for testing. Overburdened central laboratories often do not even manage to test these samples.
As part of the MoU, the state or Union Territory will provide their share of the total expenditure for setting up a new laboratory/ or strengthening an existing facility from their own resources. The Centre and states’ shares will be in the 75:25 ratio except for Jammu and Kashmir, Himachal Pradesh, Uttarakhand, Sikkim and the seven northeastern states where the ratio will be 90:10. The staffing norms too have been laid down in such a way as to ensure that for every 200 pharmacists’ shops, there would be one drug inspector.
“The total budget for revamp of the entire drug regulation machinery is Rs 1750 crore and we are hoping to sign MoUs with all states by the end of this financial year. We have prepared an indicative list of equipment, manpower and space, etc. required for different levels of laboratories. We will pay for the physical infrastructure, states will have to ensure there is adequate manpower,” explained a senior official in the ministry.
The Centre is also planning to set up a national drug regulation training academy for conducting foundation and refresher courses for officials in the drug regulatory setup at the central and state levels.