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LATEST NEWS UPDATES | Government curbs power of regulator to cap HIV, cancer drug prices -Rupali Mukherjee

Government curbs power of regulator to cap HIV, cancer drug prices -Rupali Mukherjee

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published Published on Sep 24, 2014   modified Modified on Sep 24, 2014
-The Times of India


MUMBAI: In a move that will disappoint many patients, the government has withdrawn certain powers of the drug pricing regulator that allowed it to cap prices of widely prescribed anti-diabetes, cancer, HIV, tuberculosis and cardiac medicines.

The National Pharmaceutical Pricing Authority (NPPA) said it is withdrawing "with immediate effect" - a guideline that had allowed it to put price caps on crucial medicines - to comply with a government "direction". The guideline had been issued on May 29, just three days after the Modi government was sworn in.

Although the NPPA's sudden notification does not mention whether it is revoking the price caps which it had announced on 50 anti-diabetic and cardiac drugs in July, the development could have negative fallout, sources said. A wider and more serious impact will be that impending price controls on expensive treatments of cancer, HIV and tuberculosis now stand cancelled.

NPPA officials were not available for comment, but sources say the government succumbed to pressure from industry lobbies. The NPPA's decision to impose price controls had been hotly contested; with the industry up in arms against what it said was "arbitrary implementation of the policy".

In effect, NPPA has withdrawn guidelines for price control issued under Para 19 of the Drug Prices Control Order (DPCO) 2013, which authorized it to control prices of drugs that are not under the NLEM (National List of Essential Medicines) under "extraordinary circumstances" and in "public interest".

In July the NPPA, in a rare invocation of the lesser-used provision, had fixed prices of 50 anti-diabetic and cardiovascular medicines. This was the first time the government had brought drugs, outside the national list of essential medicines, under price control. (Prices of 652 drugs under NLEM were fixed by the government last year under DPCO 2013).

The move had triggered of a series of protests and lawsuits from the industry against the drug pricing regulator as they feared more such action.

"In compliance with the directions received from the government in the department of pharmaceuticals ... The aforesaid internal guidelines issued by the NPPA on May 29, 2014 under Paragraph 19 of DPCO 2013 are hereby withdrawn with immediate effect," NPPA said in its latest notification posted on its website.

The industry welcomed the move saying that the interpretation of the May guidelines was erroneous.

"We have always contended that the guidelines for Para 19 were erroneous. Para 19 is not the right provision for extension of price control as there is no public health concern which could have prompted the NPPA to invoke the provision," D G Shah, secretary general of Indian Pharmaceutical Alliance, said.

Though it is still trying to figure out its implication on companies, the industry body representing multinational firms, the Organisation of Pharmaceutical Producers of India, said: "We appreciate the government's decision to withdraw the guidelines on fixation/revision of prices of scheduled and non-scheduled formulations under Para 19 of the DPCO 2013. This welcome move tells us we are being heard and we look forward to working with the government toward a common goal."

The industry expects that the NPPA will take a decision on whether to revoke the price reduction order, over the next few days. The next hearing of the OPPI court case against NPPA is slated for September 29.


The Times of India, 24 September, 2014, http://timesofindia.indiatimes.com/business/india-business/Government-curbs-power-of-regulator-to-cap-HIV-cancer-drug-prices/articleshow/43276718.cms


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