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Pharma & Health Ministries Together? Drug Cos Worry

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Prime Minister Narendra Modi’s “minimum government, maximum governance” mantra has kept the Indian pharmaceutical industry waiting as they fear that the restructuring exercise may see the department of pharmaceuticals, which regulates the prices of medicines, get attached to the health ministry – the government arm responsible for the quality of medicines – instead of it current parent ministry, the Ministry of Chemicals and Fertilisers.

The pharmaceutical industry’s concerns stems from the fact that the primary mandate of the department of pharmaceuticals is the promotion of the industry,  unlike that of the health ministry which is more concerned about the health of the patient than the health of the industry.

The basis of the fear is an expert committee report which recommended the change. The High Level Expert Group Report on Universal Health Coverage (UHC) for India, instituted by Planning Commission, had recommended in public interest, “the transfer of the functioning of the Department of Pharmaceuticals, which is now under the Ministry of Chemicals and Fertilizers to the Ministry of Health and Family Welfare” in November 2011.

Read Also: Will Try To Bring Down Drug Prices By 25-40%: Ananth Kumar
 
Chaired by Dr K Srinath Reddy of the Public Health Foundation of India, the committee recommended that by “bringing in both the manufacture of drugs as well as drug price control, the Ministry of Health and Family Welfare will not only be responsible for ensuring the quality, safety and efficacy of drugs but also accountable for the unhindered availability of all essential drugs under the UHC system”.

This will also help better align drug production and pricing policies to prioritized national health needs, the report added.

Global practices in drug regulation involve a variety of functions and mechanisms that range from food control, drug quality and safety, pharmaceutical price regulation and medical devices and equipment standardisation. In India, only some of these functions are undertaken by the Central Drugs and Standard Control Organisation (CDSCO) of the health ministry, while there are multiple additional authorities and departments that fail to coordinate among themselves for efficient and effective functioning.

The committee points out that while the Department of Pharmaceuticals under the Ministry of Chemicals and Fertilisers is responsible for drug price control, the Essential Drug List, or the list of medicines that needs to be brought under price control, is prepared by the Ministry of Health and Family Welfare. “Therefore, there is a need to integrate the role of drug price control into the CDSCO. In addition, the CDSCO should responsibility for collecting, tabulating and disseminating data on drug production, category-wise sales, company level information on drugs and undertake the responsibility of carrying out prescription audits”, the report notes.

It also points out that currently, various ministries rely on private data on drug consumption (which is both expensively priced and whose methodology is not very robust) to formulate drug price policies.

If the minimum government policy is implemented in this sector, the pharma department could be a fit case for being moved to the health ministry.

Though for now, it seems unlikely as the new Chemical minister, Ananth Kumar, had reduction of medicine prices on his priority agenda list when he met the media after taking charge as minister on Wednesday. He said that he will talk to the pharmaceutical companies to see if prices of essential drugs can come down by 25-40 per cent. While pharmaceutical industry can take Kumar’s assertion over the department as a sign of status quo, price reduction is the last that the companies would want to happen.

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