Monday, 10 April 2017

Centre's move to shift DoP, NPPA under health ministry viewed game changer for Indian pharma

Nandita Vijay, Bengaluru, Monday, April 10, 2017, 08:00 Hrs  [IST] PharmaBiz

Union government’s plan to shift the department of pharmaceuticals and NPPA under the Ministry of health could turn out to be a major administrative step on the Indian healthcare landscape, noted pharma experts and the industry. They view it as game changer for the sector provided its happens in a time bound manner.

According to Dr B R Jagashetty, former National Adviser (Drugs Control) to MoHFW & CDSCO and former Karnataka drugs controller, all issues related to medicines be it biotech, Ayush and veterinary should come under the umbrella of the Ministry of Health and Family Welfare(MoHFW).

“Though there is nothing wrong in having a separate full-fledged Ministry combining the issues of both drugs and food like that of Maharashtra, the present decision to bring DoP and the NPPA under the MoHFW instead of having a separate ministry of pharmaceuticals, is relevant and a welcome move. However, its implementation needs to be fast-tracked,” said Dr. Jagashetty.

Currently, biotech is under the information technology department. Now this sector deals with fermentation technology for the development of monoclonal antibodies which needs drug approvals. Therefore it should also come under MoHFW, he added.

While the government is toying with the idea of having more than one secretary to man the MoHFW, Dr. Jagashetty begs to differ on this and calls for one authoritative official to oversee the operations. The medicines quality standards, its pricing or any issues concerned with public health should be only approved by the DCGI office and related state drugs control departments which will be functioning under MoHFW.

With regards to NPPA, Dr. Jagashetty pointed out that once this body comes under the MoHFW, the government will need to stall the frequent revision of drug prices which is causing considerable confusion to the industry, distributors and patients. Hence the government with the assistance of DCGI should consider a decision to revise drug prices only twice or thrice a year. The frequent change in prices is also resulting in loss of inventory which includes packaging, labelling and stocking, besides being a national burden.

Kaushik Desai, Gen. Secretary, Indian Pharmaceutical Association and pharma consultant noted the if the move materialises, it is laudable. There will be only one Ministry accountable for making quality medicines affordable and accessible. It will result in better interdepartmental coordination between NPPA, CDSCO and DoP. If done effectively, it will help in ease of doing business in the true sense and support industrial growth.

“Moreover, it would bring some relief to industry as any new notification will be weighted by DoP before release. We hope it will bring clarity on the frequent changes in drug pricing by making it patient friendly,” said Desai.

Viewing the proposed move by PMO to bring NPPA & DOP along with CDSCO as a step in the right direction, Harish Jain, secretary, Karnataka Drugs and Pharmaceutical Manufacturers Association pointed out that it will lead to better co-ordination and avoid duplication of efforts.

“However, whether all these departments should come under Health Ministry is open to debate. Instead, PMO should look at total revamp rather than adopt a partial approach. There should be a mega Ministry of Life Sciences comprising pharmaceuticals, Ayush, vaccines & sera, biopharmaceuticals, medical devices and nutraceuticals, headed by a minister of cabinet rank. It can oversee licensing, testing enforcement, NIPER, Export Promotion Councils, Jan Aushadhi, besides create appellate tribunals for speedy settlement of disputes", said Jain.

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