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IDMA presents action plan for APIs to CDSCO

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It also covered issues of APIs production, constraints faced by industry and guidelines to tackle emergency situations

Indian Drug Manufacturers’ Association (IDMA) has recently presented a report to Drug Controller General (India) DCG(I) on current status and future requirements of Active Pharmaceutical Ingredients (APIs) in the country, action plan, guidelines for emergency situations. It followed a meeting on July 10, at DCG(I) office in New Delhi wherein IDMA representatives and DCG(I) along with a few members from the industry and regulators had discussed on API production in the country, constraints faced by the industry and steps that need to be taken to combat emergency situations.

In the submitted report to the regulatory authority, IDMA recommends a two-pronged approach to meet the requirement for APIs indigenously. It has asked CDSCO to support existing manufacturers to expand into other products and make Chinese imports costlier, thereby encouraging local units to take up production of the same. It has also recommended strict mandatory inspections of manufacturing facilities and higher registration/inspection fees of APIs imported into India in line with government draft notification (GSR 1101 dated December 29, 2015) to encourage only genuine and quality API manufacturers are encouraged and enable Indian companies to compete on a more level playing field.

As a second stage, IDMA states that the government should lend support to restart production of some of the important medicines which were already made in the country. These would include measures such as cheap and stable power, Ministry of Electricity and Energy (MoEE) support for speedy clearances including product change, revival of public sector in JV with European/US giants, fiscal benefits, interest subvention for API and intermediates industry and land at concessional rates.

Other measures are seeking alternate source of raw material from other countries, identifying biocatalysts-driven technologies to reduce number of chemical processes and pollution, developing or procuring high-end technologies for PSUs/private sector to produce key APIs and involving DSIR labs/ universities in development of cost-effective technologies for import of substitution products.

The action plan

IDMA has recommended short, medium and long-term plans for self sufficiency in API manufacturing segment.

For the short term, it recommends simplification approval process for APIs, shortening the time for addition of WHO-GMP/COPP new product, and that NOCs should not be made export order specific.

It has also suggested Ministry of Environment, Forest and Climate Change (MOEF) to build enough Common Effluent Treatment Plants (CETPs) in a given cluster, monitor the quality of discharge of central effluent treatment plant and ensure that there is no need to obtain prior permission for product change.

For the mid-term, IDMA recommends creation of API production hubs like China and Singapore. Financing small scale manufacture for upgrading GMP, pollution, health and safety related factors is another measure it suggests.

In the long term, its action plan includes creation of indigenous capacity through PSU joint ventures in capital intensive, low value high consumption starting materials/ intermediates.

Guidelines for emergency situations

To be ready for future emergency, we need to have some capacities for a few essential drugs. “Foreseeing the emergency situation, we have asked our member pharma companies to keep six months stock of APIs. Meanwhile, we are in the process of formulating memorandum of understandings (MoUs) strategies with other countries,” IDMA source informed.

The guidelines advises companies to maintain three to six months stock of APIs/ intermediates which are imported from China. It suggests the government to enter into MoUs with key friendly nations for supply of key medicines, APIs as well as build API production facilities.

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