Regulatory body takes steps to reform how it manages and monitors pharmaceuticals

Map of India overlaid against an image of pharmaceutical capsules

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India’s drugs watchdog and regulatory body, the Central Drugs Standard Control Organization (CDSCO), is creating a comprehensive national digital database of pharmaceutical manufacturers and the medicines they produce.

‘Right now, the availability of data is neither adequate, reliable nor timely and poses serious challenges,’ complains T C James, a visiting fellow at the Research and Information Systems for Developing Countries, a government funded thinktank. ‘Many manufacturing and product licences in India are granted by nearly 36 state licensing authorities and in order to ensure quality, safety, efficacy and also availability and accessibility, a national database has become extremely important,’ a senior CDSCO Official told Chemistry World. ‘At the moment, many states have their own databases on different software and all that data needs to be integrated into a centralised database,’ he added. State licensing authorities will authenticate data added by manufacturers. The CDSCO has not put any time frame on the exercise but officials say the matter is gathering speed.

‘For policy planning as well as monitoring, we need to know who produces what medicines and how,’ says long-time pharmaceutical industry watcher Dinesh Abrol, from the Institute for Studies in Industrial Development, a policy research organisation focused on public health. ‘Many state licensing authorities have been licensing irrational combinations, which should not be allowed at all, but they are being produced and marketed,’ says Abrol.

Digitisation and regular data collection will provide near real-time and comprehensive information to the authorities. New software will take care of the transition and reform the way drugs and the pharmaceutical sector is monitored and managed. As soon as the anticipated transition is effected, simultaneously, the rules governing the Drugs and Cosmetics Act and other laws will be amended and regular online inputs and updates regarding companies, their facilities and status of products will be made mandatory for manufacturers.

There have been national and international concerns about the quality of Indian pharmaceutical products, standardisation and adherence to good manufacturing practices by companies. India, being a major exporter of generic medicines, draws regular scrutiny from drug regulators in the US and Europe. ‘With such a database, medicines can be traced from raw materials to final products and their further movement and any allegation of substandard quality can be traced back to its source,’ adds James. ‘This will hugely be in India’s own interest.’