MUMBAI (Reuters) – A parliamentary committee has recommended that price caps should be extended to all drugs in the country and that the government should expedite the capping process.
The law allows the National Pharmaceutical Pricing Authority (NPPA) regulator to fix prices of drugs on a list of essential medicines, thereby keeping prices in check in a country where a majority of people live on less than $2 a day and health insurance is scarce.
But the standing committee on chemicals and fertilisers, a panel of 31 lawmakers, noted in a report tabled in parliament that all medicines should be available in the market at an affordable price.
“The committee recommend that the scope of price control needs to be enlarged to make all the drugs available, especially life saving drugs in all parts of the country,” the committee’s report said.
Reuters reported this month that all the drugs on the government’s HIV/AIDS and tuberculosis control programmes are likely to be added to the list of drugs subject to price caps.
The wide-ranging price cuts have hit both local and foreign drugmakers in India and have been opposed by many in the industry, who have said drug prices in the country are already among the lowest in the world.
(Reporting by Aman Shah in Mumbai; Editing by Greg Mahlich)
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The government has allowed pharmaceutical companies to hike rates of 509 essential medicines used for treating various ailments like diabetes, hepatitis and cancer by 3.84 per cent with effect from April 1.
Image used for representational purposes only.
The government has allowed pharmaceutical companies to hike rates of 509 essential medicines used for treating various ailments like diabetes, hepatitis and cancer by 3.84 per cent with effect from April 1.The National Pharmaceutical Pricing Authority (NPPA) has issued a notification for price hike of drugs in line with the wholesale price index of 2014 under Drug Price Control Order, 2013.”As confirmed by the economic adviser (Minister of Commerce and Industry), the annual increase in the wholesale price index (WPI) works out at 3.84 per cent during calender year 2014 over the corresponding period in 2013,” NPPA said in a notification.<!– Dna_Article_Middle_300x250_BTF –>The 509 medicines which have become costlier include Alpha Interferon injection used to treat hepatitis B and C as well as certain types of cancer, carboplatin injection used for cancer treatment, fluconazole capsules indicated for fungal infections, among others.Welcoming the decision, Indian Pharmaceutical Alliance (IPA) Secretary General D G Shah told PTI: “It is a part of the policy. Pharmaceutical companies don’t get a chance to hike prices (more than once) a year. This price hike is linked to inflation.”Prices of condoms, which are also part of the list of essential medicines, have also gone up due to cost revision.According to the notification, antibiotics which have Amoxicillin capsules have also become costlier with effect from April 1.At present, the government caps prices of a total of 348 essential medicines based on the simple average of all medicines in a particular therapeutic segment with sales of more than 1 per cent.Besides, the government regulates prices of all other medicines and companies are allowed to hike prices of such drugs by only up to 10 per cent in a year.The government had notified DPCO, 2013, which covers 680 formulations, with effect from May 15, 2014, replacing the 1995 order that regulated prices of only 74 bulk drugs.
The unitsPMRUs will provide technical assistance to state drug controllers and NPPA in monitoring notified prices, violation of provisions in DPCO, pricing compliance and availability of drugs.It will also help the regulator in monitoring price movement of scheduled and non-scheduled formulations, based on periodical returns filed by the industry, price revision of scheduled formulations by manufacturers on annual increase in wholesale price index, as per provisions contained in the DPCO and in overseeing the prices of non-scheduled formulations.The National Pharmaceutical Pricing Authority (NPPA) proposes to set up price monitoring and resource units (PMRUs) in states and Union territories to support state drug controllers and itself.In a recent notification, NPPA said it required constant liaison with state drug control departments to carry out its mandate. The support of state drug controllers is vital for sharing information on shortages of medicines and to ensure that pharma companies are fully complying with NPPA directives.NPPA also needs support for verification of pharma company documents, field investigation and testing medicine samples.At present, NPPA does not have any field unit to liaise with state drug controllers and inspectors.The regulator has, therefore, proposed to initiate a central scheme of assistance for setting up PMRUs at states and UTs.“Each unit will function under the direct supervision of the state drug controller. PMRUs will be the key collaborating partners of NPPA, with information-gathering mechanism at the grassroots level. PMRUs will also ensure that the benefits of the Drug Pricing Control Order (DPCO – revised from time to time) trickles down to the grassroots level. The central funding will be for an initial period of five years, subject to a mid-term review after 12th Plan period,” the notification said.PMRUs will provide technical assistance to state drug controllers and NPPA in monitoring notified prices, violation of provisions in DPCO, pricing compliance and availability of drugs.It will also help the regulator in monitoring price movement of scheduled and non-scheduled formulations, based on periodical returns filed by the industry, price revision of scheduled formulations by manufacturers on annual increase in wholesale price index, as per provisions contained in the DPCO and in overseeing the prices of non-scheduled formulations.Co-ordination with PMRUs will help NPPA ensure that that the prices of such formulations, even if they are increased, do not go beyond 10% annually.Sujay Shetty, executive director and leader, pharma life sciences, PricewaterhouseCoopers India, said: “If the objective is to forge linkage with state FDAs, these units will not function independently. So anything that is going to help NPPA function more efficiently is always welcome.”The objectives also include collection and compilation of market-based data of scheduled as well as non-scheduled formulations, collection of medicine samples from retail markets, conducting training, seminars and workshops at the state and district levels and publicity.The notification also said these tasks require constant interaction with various stakeholders – state departments, drug controllers, consumer groups, etc.Also, each PMRU will have to submit a quarterly return to NPPA and principal secretary/ secretary (health) of the state on targets and other pre-determined parameters in the prescribed proforma, which would form technical inputs to the government for effective policy formulation and implementation. Each PMRU will have online systems compatible with centralised online systems installed in NPPA to facilitate online linkage with the NPPA.The scheme is proposed to be implemented during the 12th Five Year Plan period and commencing from the financial year 2015-16. The continuation of the scheme in the succeeding Five Year Plans would depend upon mid-term evaluation.It has been also proposed to release the entire non-recurring and recurring grants, which is Rs 20.73 crore in the first year of its implementation — that is, during 2015-16. From the second year, only the recurring grants would be released. The total outlay required for five years, from 2015-16 to 2019-20, works out at Rs 96.85 crore.