Wednesday, April 12, 2017

GOVT BID TO CUT RED TAPE - Drug Price Regulator May Come Under Health Min

Chemicals min said to be not happy with plan to move NPPA, Dept of Pharma out of its purview
The Narendra Modi government may shift two crucial drug industryrelated departments to the health ministry from the ministry of chemicals and fertilizers as it steps up efforts to cut red tape and improve ease of doing business.
The National Pharmaceutical Pricing Authority, (NPPA), and the Department of Pharmaceuticals (DoP) could soon be shifted to the health ministry, people close to the development told ET. This will satisfy a long-standing demand of the industry and health rights group who have been clamouring for one ministry to take care of all related issues.
“This restructuring was discussed at a meeting held with Prime Minister's Office on March 28. The PMO is keen about this merger,“ an industry official who did not want to be quoted said. The chemicals and fertilizers ministry is not believed to be happy about the idea and has proposed status quo and the addition of the drugs controller general of India (DCGI) under its purview. “However, the merger with the health ministry is most likely as there is a major cabinet revamp that is expected, which would take care of these issues,“ one of the people aware of the discussions told ET. The proposed structure may also end up curbing some of the powers of the NPPA. Instead of an additional secretary who currently heads the body, the NPPA chief's post will be on a par with the DCGI, which is led by a secretary, scientific director. Any orders or decisions taken by NPPA would be reviewed by the DoP.
ET has also learnt that the earlier plan of dissolving the NPPA might not happen for now as the government has received legal notice from activist groups. An email sent to the health ministry remained unanswered till the time the story went to press. Sudhanshu Pant, joint secretary, DoP, told ET that his department does not have any information on this.
“We have been demanding to bring the DoP and NPPA under the health ministry. If this happens, it will bring some coherence. But like everything else, the devil is in the details,“ said S Srinivasan of All India Drug Action Network, an organisation that works to improve access to drugs.
India's nearly Rs 1lakh-crore drug industry has been reeling under slow growth in the last two years due to price controls imposed by the government. In February, in a curt letter to Niti Ayog vice-chairman Arvind Panagariya, the Indian Pharmaceutical Alliance (IPA), the lobby group of top Indian drug companies, complained that constant price cut measures by the regulators were harming the industry.
“We shared our concerns regarding the overreach of the pricing regulator on drug price cuts, and we were assured by the government that they were correcting the situation,“ an industry official, who did not wish to be identified because of the sensitivity of the issue, told ET. “In the new structure, the DoP will be reviewing every order passed by both the regulators“, this source added. “The last couple of years have been very unsettling for the pharmaceutical industry in India. It has become a nightmare not because the pricing policy is defective. Problems have cropped up because of the imaginative and arbitrary implementation of the pricing policy and unbridled turf war between the government and the regulator,“ said a note by DG Shah, secretary general, IPA, in the letter to Niti Ayog. “This has resulted in unwarranted price fixation, open defiance of the government's corrective orders by the regulator and frustrating litigations for the industry. It has reached a stage where the industry wonders if the country has a rule of law,“ the letter said.
The current NPPA chairman Bhupendra Singh has faced the ire of the medical devices and pharma industry over his orders on price cuts and new stent pricing policy.In February, the NPPA slashed prices of stents by 85% after a direction from the Delhi High Court demanded action to address a public interest litigation that sought stent prices to be made affordable. This prompted the health ministry to include stents in the National List of Essential Medicines (NLEM).After months of negotiation, the DoP added stents in Schedule 1of the Drug Price Control Order (DPCO) 2013, which made way for the price cut.

Source: THE ECONOMIC TIMES-6th April,2017