Inability to regulate drug prices: Parliamentary committee blames pharma dept’s ‘lackadaisical attitude’

‘Gross negligence’, ‘lackadaisical attitude’, ‘vested interests’, these are some of the terms used by a Parliamentary Committee for the Department of Pharmaceuticals (DoP) on the latter’s inability to regulate the prices of patented medicines even after nine years of deliberation on the same. The scathing indictment of the DoP, which functions under the Ministry of Chemicals and Fertilizers, in the report submitted by the

Parliamentary Committee on ‘Government Assurances’ on August 11 comes at a time when the NDA government has been taking credit for bringing more generic medicines under price control.

“The previous government had kept just 400 (generic) drugs under pricing control. On the other hand, Modi government has added another 450 drugs under the pricing control in 18 months, taking them to 850,” Ananth Kumar, Minister of Chemicals and Fertilizers, had said in January this year. Price control of patented medicines, which rakes in big money for major pharma companies, though, has been deemed by the Parliamentary Committee as an issue generating “consternation” because of the “professional” inaction of both the Central governments in power since 2007 — the UPA as well as NDA.

The DoP had formed the first committee on price regulation of patented drugs in 2007 under the UPA government. After much bickering among its members and subsequent delays, it submitted its report after five years in June 2012. The government “examined” this issue for almost 15 months and without taking any decision on the recommendations of the first committee, it formed another Inter-Ministerial Committee of joint secretaries in November 2013 on the same issue.

While the NDA government has been in power since 2014, the second committee is yet to submit its report.”Such a lack of professionalism and careless approach is at a time when the country has been facing serious issues in fixation and monitoring of the prices of patented drugs which tend to be too high to the detriment of the people at large whose sufferings are compounded as the patented drugs are mostly used for serious ailments or deadly diseases,” said the Parliamentary Committee headed by BJP MP Ramesh Pokhriyal ‘Nishank’.

The comprehensive product patent regime was introduced in India from the onset of 2005. It meant that if a pharmaceutical company has innovated a drug and has got the patent (licence) for it, only that company would be allowed to manufacture, market the drug and eventually make profit from it for a certain period of time. Once that period is over, other pharma companies can manufacture that drug too — such copycat drug is called ‘generic’ drug.

Understandably, from 2005, the government started facing various questions on rising prices of patented medicines. It then formed the first committee to negotiate price control on such medicines in 2007 which had members from DoP, Drug Controller General of India (DCGI), National Institute of Pharmaceutical Education and Research (NIPER), NPPA, Department of Industrial Policy and Promotion (DIPP) and Pharmaceutical Export Promotion Council of India (Pharmexcil).

According to current secretary of DoP, who deposed before the Parliamentary Committee, the 2007 committee recommended that the country should enhance its insurance security and then distribute drugs to the people. It did not make any suggestions on fixing the price of patented drugs.”It is highly questionable as to why the ministry allowed that committee to submit its report in the matter after five years in 2012 that too without unanimity if not for gross negligence and lackadaisical attitude or vested interest. Evidently, the ministry lacked will in this regard and did not pursue the matter in the right earnest,” the Committee noted.

As the 2007 committee had not given any actionable recommendations, the government ended up setting up a new committee in order to get a “firm recommendation”. “That committee has also taken some time…is likely to hand over the report in another 10 days time,” the secretary said.

Coming down hard on the delay of the second committee, the Parliamentary Committee said “it is not a good sign of professionalism and ought to have happened much before”. In the end, the Parliamentary Committee said: “The Committee would like the ministry to take the proactive steps to expedite proper follow action to finalise the requisite mechanism of patented drugs at the earliest and in the best interest of the country so that these medicines are made available to the common people at most affordable rates.”