Drug Information Bulletin

Drug Information Centre (DIC) Indian Pharmaceutical Association

Bengal Branch Tele fax: 033 24612776, E-mail: ipabengal.dic@gmail.com Web Site: http://www.ipabengal.org Contact: 09830136291

Volume: 06

Number: 33

25th November 2012

Content Govt clears pharma policy, caps prices of 348 drugs Forxiga (Dapagliflozin) approved in European Union for treatment of type 2 diabetes India slips 23 places in pictorial campaign against tobacco Forthcoming Event The proposal was even turned back from the Cabinet Secretariat following the ministrys objection to the market-based pricing mechanism suggested by the GoM. On Wednesday, GoM made three key changes to its earlier proposal to bring Chidambaram on board and get the policy to Cabinet for an approval. This was significant as the government has a Supreme Court deadline of November 27 hanging over its head, before which it will have to notify the policy. Earlier, the GoM had recommended a price cap based on weighted average of all drugs, which would have reflected the price of expensive drugs with better market share more than those with a lower market share. The GoMs suggestions also included that any company changing the composition of the 348 essential medicines by adding a new ingredient to the formulation would come under price control and would have to seek permission from the pricing authority. The idea is to prevent companies from circumventing price control by adding

Govt clears pharma policy, caps prices of 348 drugs The Union Cabinet today endorsed the Group of Ministers' (GoM) recommendations on the National Pharmaceutical Pricing Policy, giving shape to a long pending policy that will have ramification not only on the drug manufacturing industry but also on interests of the common man. The government did not give out the details of the Cabinet decision on the pharma pricing policy. According to sources, the Cabinet has imposed a cap on prices of 348 essential medicines at the arithmetic average of prices all drugs in a particular segment with more than one per cent market share, in line with GoMs new recommendations. The GoM, headed by Agriculture Minister Sharad Pawar, convened a last minute meeting on Wednesday with Finance Minister P. Chidambaram as special invitee to address concerns raised by the finance ministry on the GoM earlier suggestions.

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new ingredients to essential medicines. The earlier recommendations of the GoM included only 348 formulations under price control, while companies were free to price combinations of these drugs. Another major recommendation of the GoM is that the price regulator would review prices of drugs periodically instead of five years as was earlier suggested by the ministerial panel. Sources said the Cabinet has approved the proposed policy without any further changes. Though the new policy is expected to lower prices of various expensive drugs, there is also immense scope that prices of many low cost drugs would now be relatively higher. The GoMs new recommendations have found mixed reception from the industry. While some of the companies are relieved that the government has not accepted finance ministrys recommendations in favour of the existing cost-plus mechanism for capping prices, which was also in line with a previous SC observation, other feel the simple average would impact the industrys revenues going forward. Half of the industrys profit is wiped out because of the simple average formula. There are two basic objectives of the policy access and availability. While the government has achieved access through this policy, I am not sure whether all medicines would be available with this kind of policy in place, said D.G. Shah, Secretary General, Indian Pharmaceutical Alliance that represents all top domestic pharmaceutical companies including Ranbaxy and Cipla who are seen to be highly impacted. However, Lupin India Group President Shakti Chakraborty said, It is a good thing that the government has chosen to adopt a market based mechanism thus protecting industry interest to a large

extent and also ensuring that drugs reach patients in a cost effective manner. So far, the government was regulating prices of medicines based on cost plus method taking into account the cost of bulk drugs. Under this mechanism, prices of 74 bulk drugs were capped and any medicine formulation containing one or more of these bulk drugs or ingredient would fall under price control. The companies were required to seek a price approval for any such drug from the National Pharmaceutical Pricing Authority. Besides, for all other medicines, drug makers were allowed to raise their prices by up to 10 per cent annually and for any hike beyond that they were required to seek permission from the regulator. However, the new policy is a deviation from the existing one. The new pricing mechanism is market based and the ceiling price will reflect prices determined by various companies for their different brands. The move has not gone down well with health activitsts and groups advocating for a cost-plus mechanism. In a statement, issued by Jan Swasthya Abhiyan, a patients group, demanded that the government should heed the SCs opinion and impose price control on all 348 essential drugs and their derivatives, using the existing cost based formula for price fixation. Now what remains to be seen is whether the Supreme Court accepts the decision of the government bringing an end to a nine year long pending case. Forxiga (Dapagliflozin) approved in European Union for treatment of type 2 diabetes AstraZeneca and Bristol-Myers Squibb have said the European Commission has approved Forxiga (Dapagliflozin) tablets for the treatment of type 2 diabetes in the European Union (EU).

Forxiga is a selective and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2) that works independently of insulin to help remove excess glucose from the body, a unique mode of action not seen in any other currently available treatments for type 2 diabetes. This is the first medicine in the new SGLT2 class to gain regulatory approval for the treatment of type 2 diabetes, a disease in which high unmet medical need exists. Forxiga tablets are indicated as a oncedaily oral medication to improve glycaemic control in adult patients with type 2 diabetes. Forxiga is intended to be used as an adjunct to diet and exercise in combination with other glucose-lowering medicinal products, including insulin, or as a monotherapy in metformin-intolerant patients. For details: http://www.aalatimes.com/2012/11/18/fo rxiga-dapagliflozin-approved-in-europeanunion-for-treatment-of-type-2-diabetes/ India slips 23 places in pictorial campaign against tobacco India has been ranked 123 among 193 countries in an international biennial report on pictorial health warning campaign against use of tobacco products slipping 23 places behind its 100th rank in 2010. The Cigarette Package Health Warnings: International Status Report was released at the World Health Organisation (WHO)s Framework Convention on Tobacco Control (FCTC) conference in Seoul, South Korea, said an official statement issued by Voluntary Health Association of India (VHAI). India was at the forefront in demanding effective and visible picture-based health warnings on tobacco packs at the negotiations of FCTC in 2003. It is

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regretful that India occupies the 123rd position among countries which have introduced health warnings, said Bhavna Mukhopadhyay, executive director, VHAI. In 2004, India signed and ratified FCTC that required it to carry health warnings on tobacco products packets describing the harmful effects of tobacco use on health a proven strategy to deter people from smoking or chewing tobacco. The warning should be 50 per cent or more of the principal display areas, but shall be no less than 30 per cent of the display areas, according to FCTC. Although India introduced pictorial warnings on packets of tobacco products in 2008, the new report shows the country lags far behind many countries in giving optimum space to health warnings on tobacco products packs. Indias tobacco pack warning covers only 40 per cent of the front panel, while there is none on the rear side. This pushed India to the 123rd rank, compared to Pakistans 65th and Bangladeshs 97th rank in the report, the VHAI statement added. Australia, which has been ranked first in the report, gives 82.5 per cent space to pictorial warning on tobacco product packs, while Uruguay and Sri Lanka which jointly hold the second rank dedicate 80 per cent space to health warnings on the packs. A survey by the Global Adult Tobacco Survey says India has nearly 274.9 million tobacco users, the third-largest in the world. Tobacco kills nearly one million people every year due to related diseases such as cancer, heart and lung illness. The international status report on pictorial health warnings was first released in 2008. [Source: IANS] NBRA Bill may get through during winter session of Parliament began on Nov 22 The much awaited Biotechnology Regulatory Authority of India Bill, 2012

(known as NBRA Bill), which has repeatedly been finding a place in the tentative list for transaction of business for the last several sessions of Parliament, may ultimately get through during the ongoing winter session of Parliament that began on November 22. This is the only Bill related to pharma and health sectors which has found a place in the list of new Bills lined up for introduction in Parliament during this session. There is optimism among the officials that the NBRA Bill may ultimately be introduced in Parliament during this ongoing session as this is one of the 10 Bills which have been earmarked for introduction in Parliament during this session. As the number of new Bills listed for introduction is very less this time, there are chances that all the 10 Bills may be introduced this time. Till the last session, there used to be around 35 to 40 new Bills queuing up for introduction. Sources said that though there are several Bills related to pharma and health sectors which have been waiting in the wings to be introduced in Parliament for its final nod, only NBRA Bill may be introduced during this session as other major bills are are entangled in various departmental procedures before being introduced in Parliament. While other bills like ART Bill, HIV/AIDS Bill, Ethical Guidelines for Biomedical Research on Human Subjects Bill, Medical Devices Bill, etc. are pending in different government departments for clearance, the NBRA Bill has already cleared all these technical and bureaucratic hurdles and the introduction of the Bill in during this session, which is scheduled to conclude on December 20, is almost certain, sources said.

The NBRA Bill seeks to establish Biotechnology Regulatory Authority of India to regulate research, import, transport, use of organisms and product produced from modern biotechnology. The Bill, drafted by the Department of Biotechnology (DBT), also seeks to make NBRA as an independent, autonomous, statutory agency to safeguard the health and safety of the people of India and to protect the environment by identifying risks posed by, or as a result of, modern biotechnology, and managing those risks through regulating the safe development and deployment of biotechnology products and processes in the country. Forthcoming Event: 64th Indian Pharmaceutical Congress, Chennai 07-09 December 2012 at SRM University Chennai, INDIA. Hosted By: Association of Pharmaceutical Teachers of India (APTI) Venue: SRM University SRM Nagar, Kattankulathur - 603 203 Kancheepuram District, Tamil Nadu, INDIA www.srmuniv.ac.in www.64ipcchennai.com Annual Meeting & Exposition For information, write to: Dr N Udupa Convener Scientific Services Committee Indian Pharmaceutical Congress Association Manipal College of Pharmaceutical Sciences Manipal University Manipal 576 104, Karnataka, INDIA Email ID: ipcssc.info@gmail.com

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