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"Medicine price regulator National Pharmaceutical Pricing Authority (NPPA) has proposed the formation of a centralised agency to negotiate the prices of patented medicines. The NPPA said the agency should estimate the market potential of the patented products and negotiate the prices on the basis of a reference pricing system.

The NPPA’s suggestion is being considered by an official committee assigned with the task of recommending a system of price negotiation for patented medicines to make the prices reasonable for Indian patients.

According to official sources, the NPPA has suggested that the reference prices should be calculated after comparing the prices of the same medicines in other countries with comparable per capita incomes or purchasing power parity. The reference price should be either the lowest of, or an average of the prices prevalent in comparable markets, the NPPA said.

The agency also wanted a nodal agency to be nominated for the bulk purchases of patented medicines to ensure that supplies are delivered at the negotiated price. An NPPA note to the committee suggested that the nodal agency release the medicine for retail sales through normal trade channels at the procurement price."

IP patent NPPA drugs price-control

A report prepared by the London-based International Policy Network (INP) could be greatly responsible for shaping the anti-Indian generics policy mindset that many of the African countries have either adopted in recent past or are in the process of adopting. This report, ‘Keeping it real: combating the spread of fake drugs in poor countries’, is learnt to be in wide circulation among the African countries and is being referred to. The governments of these countries conclude that India and China seem to be the largest producer of fake medicine.

It infers so on the basis of estimates derived from various secondary sources such as European Commission, The Associated Chambers of Commerce and media reports.

A 2004 survey of medicines on sale at a large bazaar in New Delhi found that only 7.5% were genuine. A report in a newspaper said that fakes are freely sold to exporters who sell them to unsuspecting health administrators in Sub-Saharan Africa, who receive some of the millions in aid money.

International Policy Network generics drugs pharma fakes spurious-research

Two weeks ago Justice S Ravindra Bhat of the Delhi High Court dismissed with costs the writ petition filed by the German pharmaceuticals giant Bayer Corporation against the Union of India, the Drug Controller General of India (DCGI) and Cipla. The importance of Justice Bhat’s judgment cannot be overestimated. It is a clear — and sharp — judgment that puts paid to attempts by foreign companies to modify India’s regulations to suit their commercial interest.

The judge characterised the litigation as “a speculative foray; an attempt to ‘tweak’ public policies through court mandated regimes” and, in a first of its kind, awarded costs of Rs 6.75 lakh. The amount, far from being punitive, is to be shared by the government and the third respondent Cipla, one of India’s top drug companies. However, the point that the judgment makes is strong: Companies with deep pockets may “achieve short term goals of keeping out competitors through interim orders” but the court will impose ‘realistic costs’.

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Andhra Pradesh chief minister Y S Rajasekhara Reddy on Wednesday agreed for restructuring the government hospitals in the state in tune with the requirements of the Aarogyasri scheme, which provides cashless treatment to the poor.


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The health department prepared a blueprint for revamping the policies, support services, infrastructure and restructuring the staff of government hospitals.

The government proposed to increase the participation of government hospitals in the Aarogyasri programme from the present 9 per cent to 30 per cent in a year by creating better infrastructure and staff.

health pharmaceuticals pharma medicines drugs Andhra-pradesh

Medicines sold at government-set prices have become cheaper by nearly 3% after the country’s drug price regulator ordered a price cut
in the wake of the recent cut in excise duties.

The government last weekend announced a 4% cut in excise duties as part of a fiscal stimulus package to boost the economy. Various industries, most notably the automobile industry, have announced price cuts as companies look to pass on the benefits of the duty cut to consumers to boost demand.

The drug price regulator — the National Pharmaceutical Pricing Authority (NPPA) — notified the 2.84% price cut on Thursday and its decision is effective immediately. The price cut will cover about 17% of the Rs 45,000-crore domestic pharmaceutical market. The market segment affected by the price cuts has revenues of Rs 7,800 crore, industry officials say.

pharma drugs price-control medicines excise NPPA

Indian pharma major Lupin has sent a legal notice to US-based Oscient Pharmaceuticals to inform them that they are seeking regulatory appr
oval for a generic version of Oscient’s cholesterol drug, Antara. Oscient received a notice to this effect on Wednesday, its official website said.

The notice stated that Lupin had filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (USFDA) to launch a generic version of Antara in the market. The notice alleges that US Patent No. 7,101,574, owned by Ethypharm, exclusively licensed to Oscient and listed in the FDA Orange Book for Antara, is invalid and will not be infringed by Lupin's manufacture, use or sale of the product. US Patent No 7,101,574 will be expired in 2020, the website stated.

Lupin pharma drugs generics Oscient Antara

The risk of India’s generic drugs being labelled counterfeit under the new definition proposed by WHO has receded, a government represe
ntative concerned with the issue said. This would ensure that India’s manufacturers continue to sell their drugs in foreign markets.

The WHO-funded International Medical Products Anti-Counterfeiting Taskforce (IMPACT) had proposed a new definition of counterfeit drugs as medical products with a “false representation about their identity, history or source”.

drugs generics WHO IMPACT counterfeit pharmaceuticals IP

The proposal to create a National Biotechnology Regulatory Authority (NBRA), for which a draft bill is now in circulation, is being moved in an unprofessional manner by the Government of India.

The bill is driven by the Department of Biotechnology. The DBT ought to know that biotechnology covers some 30 areas, of which many need to be regulated. These areas include stem cells, nanobiotechnology, biological warfare, vaccines, bioinformatics, organ transplantation, new drug delivery systems, new materials such as spider silk and bacterial ropes, plant-based traditional drug formulations, and assisted reproductive technologies. But the proposed bill is confined to Genetically Manipulated Organisms (GMOs) and their products. Should it not, therefore, have been called a National GMO Regulatory Authority instead of an NBRA? Biotechnology cannot be equated with genetic engineering. If the DBT really thinks so, it ought to change its own name to “Department of Genetic Engineering.”

The bill has a range of other problems as well.

The objective of any proposed bill should be to fill a defined void. There is already a regulatory procedure in place for GMOs and their products, involving the Review Committee on Genetic Manipulation (RCGM) of the DBT and the Genetic Engineering Approval Committee (GEAC) of the Ministry of Environment and Forests. Therefore, it should first be determined if anything is wrong with the present system. Then an attempt should be made to correct the existing system. Only if this is not possible should a new bill be considered. The authorities concerned should state what part of the existing procedures is undesirable and how the proposed bill will correct it. For example, the present system does not prescribe any penalty for contamination of a non-GMO farm by GMOs in an adjoining farm. The proposed bill is silent on such problems.

biotechnology NBRA drugs pharma

The way the actual testing works is that the sponsor clears every project with the Drug Controller General of India (DCGI) and, as part of the process, has to have a Management Committee, an Ethics Committee and a Data Safety Management Board; there are then various monitoring committees and the DCGI is training people to ensure these guidelines are being followed. The structures are all there and the larger trials, by the Bill and Melinda Gates Foundation for instance, are being done under these rules. But much of this is self-regulatory and there will be lapses. The rules and their implementation are being strengthened and as the support eco-system gets better, the chances of regulatory failure also decline. In another five years, India will have a very strong clinical trials environment in place.

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Ranbaxy expects the settlement with Astrazeneca on Nexium, the world's second largest selling drug with annual global sales of around $5.5 billion, to fetch $1.5 billion in exclusive sale of its generic version and supply of raw materials. The out of court settlement with Pfizer on Lipitor is expected to generate even more revenues in the coming years.

By doing out of court settlements, Ranbaxy has opened multiple revenue streams from these products. Apart from generic clones, it can supply authorized generics as well as bulk drugs to some of these innovator companies.

Settlement of patent litigations, said the source, has brought certainty to the company's cash flows, besides saving it millions of dollars in legal fees. Ranbaxy still has 14 patent challenges going on at the moment. However, the source said, it may not settle all of these out of court.

ranbaxy pharma pharmaceuticals drugs patent ip Daiichi Sankyo

Bangalore:The death of 49 babies in clinical trials at the All India Institute of Medical Sciences (AIIMS) in New Delhi may have opened a Pandora's box as two of the trial drugs have never been tried on patients below 18 years, an expert said.

How many of the children died because of the trial drugs will be known only when an enquiry committee submits its report this month, but doctors have already raised questions of ethics.

In reply to a Right to Information (RTI) query, the AIIMS said that 49 babies had died during clinical trials over the past two-and-a-half years.

The AIIMS paediatrics department conducted 42 sets of trials on 4,142 babies - 2,728 of them below the age of one - since Jan 1, 2006.

Two of the trial drugs - olmesartan and valsartan, meant for reducing blood pressure - have never been tried on patients below the age of 18 years, said Chandra M. Gulhati, editor of the Monthly Index of Medical Specialties and a keen obserger of the clinical trials in India.

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Japan's Daiichi Sankyo's proposal to acquire Ranbaxy will go to the Cabinet Committee on Economic Affairs (CCEA) for approval. Any foreign deal exceeding Rs 600 crore has to be approved by the CCEA under the existing policy.

Industry secretary Ajay Shanker told reporters that he does not see any problems related to the Tokyo-based Daiichi Sankyo's controlling bid on Ranbaxy Laboratories. The takeover is valued at $ 4.6 billion (Rs 19,780 crore).

The open offer by Daiichi to acquire upto 20 per cent of Ranbaxy's shares will close on September 4

ranbaxy business pharmaceuticals Daiichi Sankyo CCEA drugs

he fierce battle in the retail pharma space is set to reach new dimensions, as drug retailers have started entering into exclusive tie-ups with drug manufacturing companies. The All Indian Origin Chemists & Distributors Limited (AIOCDL), the newly formed company with 5 lakh chemists across the country as members, is set to sign an exclusive tie-up with a Mumbai-based drug manufacturer. The deal is seen by many as AIOCDL’s strategic move to thwart the growth of retail pharmacy chains belonging to corporate giants in the country.

According to the deal, the manufacturer, Maneesh Pharma, will supply its drugs exclusively to AIOCDL, and not to other organised pharmaceutical retailers. Vinay Sapte, managing director, Maneesh Pharma, told FE, “We are considering an alliance with AIOCDL. In a couple of days, the model will be finalised.” In a few markets, the drugs will be supplied exclusively to AIOCDL, he added, without refusing to disclose further.

pharma drugs business India small chemists retail

Ranbaxy has been aggressive in supplying generics, like anti-AIDS drugs, to developing countries, the company has participated in pre-grant oppositions in India (where a patent application is opposed before the Patent Office takes a decision) and it has been able to make similar versions of drugs like Tamiflu, used in the case of bird-flu, even as the patent situation was not clear.

This generic orientation could get influenced under the new owner and that would affect the supply of low-cost medicines to patients in India and other developing countries, the Centad representative said.

Corporate mergers and acquisitions in the pharma segment should not be viewed with the same lens as a regular corporate deal, as it could affect access to medicines, he added.

ranbaxy pharma drugs generics merger Daiichi Sankyo

In the global battle against counterfeit medicines, India has sought clarity on the proposed expanded definition of counterfeits, staving off attempts to equate counterfeits with generic medicines.

Counterfeiting is a trademark-related issue that affects branded, patented and generic medicines, the Indian delegation said at the recent World Health Assembly (WHA) in Geneva.

At present, the World Health Organisation defines counterfeits as medicines that are deliberately and fraudulently mis-labelled, regarding identity or source. Also, counterfeits could contain varying levels to no level of the active ingredient of the original medicine. The expanded definition refers to the “history” of the drug, bringing in several implications, a Union Health Ministry source familiar with the development told Business Line.

India has its own norms and punishments on counterfeit medicines and is not opposed to being part of global initiatives to tackle them, the source said. But, a clear global definition on counterfeits was necessary, as countries often rely on WHO’s norms and definitions when framing their laws, and an ill-thought-through definition could cast a shadow on generic medicines, the source said.

generics drugs pharma counterfeit fake WHO IMPACT

In a partial victory for Ranbaxy Laboratories in its patent litigation against Pfizer, an Australian court has ruled in favour of the Indian company in a case relating to Atorvastatin, the world’s largest selling cholesterol-lowering drug (marketed by Pfizer as Lipitor).

The court at the same time also ruled that a proposed Ranbaxy generic product under a different patent infringed Pfizer’s basic Lipitor patent.

The Federal court had ruled that one of Pfizer’s patents was invalid for inutility, false suggestion and misrepresentation in obtaining the grant of Australian patent.

Mr Jay Deshmukh, Ranbaxy’s Senior Vice President-Global Intellectual Property, noted, “We are pleased with this decision as it stands, as it advances the entry of Ranbaxy’s generic atorvastatin in Australia to May 18, 2012.”

The ruling, the culmination of a lawsuit filed in 2005 by Ranbaxy, preserves Lipitor’s patent coverage in Australia through May 2012. Ranbaxy can appeal the decision.

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In view of the robust growth of the pharmaceutical sector, the Government has decided in-principle to create a separate department dedicated to the sector, Union Minister of Chemicals and Fertilisers Ram Vilas Paswan said on Tuesday.

Addressing the media, the Minister said the proposed department for the pharma sector would be carved out from the existing chemical and fertilizer department, which is now also taking care of the sector.

Responding to a question on the demand of the Indian Drug Manufacturers Association (IDMA) for revising the ceiling prices of 33 bulk drugs in the wake of the appreciating dollar against the rupee, the Minister said, “In a situation where the profit margins are as high as 200 per cent, there is no possibility of any company closing its manufacturing business due to the price control mechanism of the government.

pharma drugs NPPA IDMA pharmaceuticals regulation

In an effort to facilitate the fast growing Indian pharma industry to position itself globally, Drugs Controller General of India (DGCI) has initiated a centralised uniform system for various processes of the industry.

“Online real time system for various approvals will be fully operational within two to three,” the new DGCI DrSurendra Singh said, while inaugurating a seminar on ‘How quality pays’, organised by the Indian Drug manufacturing Association.

Singh said 60% of the delays faced by the industry was in getting test licence, export NOC and to get approval for conducting clinical trials and all these delays will be addressed by setting up a system e-governance by digitalising offices (both head office and regional offices) and having interactive portals.

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Pharma-major Ranbaxy Laboratories Ltd on Wednesday said it has commenced its operations in Yemen, strengthening its presence in the West Asian region.

Ranbaxy has tied up with Pharma Ltd (Natco) as business partners for its Yemen operations. Ranbaxy will focus on therapy areas such as anti-infectives, gastro-intestinal, cholesterol lowering and anti-allergic categories in Yemen.

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