Various domestic companies such as Ranbaxy, Wockhardt and Agila Specialities recently came under the US FDA scanner for lapse in manufacturing practices.
'The difference between black money in India and the black money out of India is, in India, it is tax evaded money and Indian money outside India is not only tax evaded money, but money which has been taken out of India's capital resources needed for India. So it is not only tax evasion, but treason too.'
Negotiations for a trade deal between India and the UK have run into fresh controversy, after the proposals under a leaked chapter of the deal on intellectual property (IP) are believed to put access to affordable, lifesaving generic medicines from India at risk. According to the draft IP chapter put out by an international trade portal bilaterals.org, the UK is seeking continuous extension of patent period and rights through small tweaks in the drug, known as evergreening. This may prevent patents from expiring, impacting cheaper drug availability and its production by Indian generic drug manufacturers.
It is now probing the quality of AIDS medicines supplied by the company to developing countries under US government-funded programmes. Estimates suggest that Ranbaxy has received over $9 million from the programme so far. Ranbaxy had a turnover of $1.5 billion in 2007-08, of which a quarter came from US sales.
Daiichi Sankyo, Japan's third-largest drug maker, has transferred six of its early drug discovery programmes in inflammatory and infectious diseases from its Japanese research & development (R&D) facilities to India.
US-based Merck is confident that its cervical cancer vaccine Gardasil will help it to secure a position among the country's top five drug companies in the next five years.
In a continuing trend for the previous two quarters, foreign currency fluctuations and mark-to- market losses are affecting profits of India's drug makers, despite increase in net sales ranging between 4.5 and 42 per cent for most of the firms during the three-month period.
Ranbaxy Laboratories has received approval from the U.S. Food and Drug Administration to manufacture and market Clarithromycin XL 1,000 mg tablets.
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"Through this partnership, the reach of Sitagliptin and Sitagliptin plus Metformin will be enhanced amongst doctors and patients in India, helping them efficaciously manage the disease," Sun Pharma Chief Executive Officer Kalyanasundaram said in a joint statement issued by the two firms.
Currently, the govt directly caps prices of 348 formulations at the average price of all medicines in a particular segment with at least 1% market share
Domestic drug makers Cipla, Aurobindo and Matrix Laboratories have emerged as the second-line and paediatric AIDS medicine supply partners to international drug purchase facility UNITAID and Clinton Foundation HIV / AIDS Initiative in 2008. UNITAID and CHAI support HIV / AIDS treatment programmes in over 100 countries worldwide.
Pharmaceutical companies in the country offering any financial incentive to doctors to prescribe particular drugs may become a thing of the past if the drug manufacturers decide to follow the strict code of conduct being implemented by a US industry trade group.
Most foreign drug makers have 100% subsidiaries in India, apart from their listed arms.
Cheap bulk drug imports from China may soon post a threat to the Rs 20,000 crore (Rs 200 billion) domestic bulk drug industry.
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In a letter to health minister Harsh Vardhan, the Indian Pharmaceutical Alliance, an industry body representing leading pharma companies, including Sun Pharma, Lupin, Dr Reddy's Labs, Cadila Health and Glenmark, stressed the need for an out-of-court settlement with health activists fighting for the rights of clinical trial participants.
Even as most of its large-cap pharmaceutical peers have struggled to stay above water on the returns front, Zydus Lifesciences has been one of the big outperformers within the sector over the past year with a return of over 30 per cent. The gains have come on the back of multiple triggers such as the scaling up of new product launches in the US market, clearance for its Moraiya (Gujarat) facility and steady performance in the domestic market. Though it has been the top pharma gainer in the 2022-23 financial year (FY23), brokerages continue to maintain their 'buy' stance, given the strong visibility in the US market.
Dr Reddy's Laboratories hopes to become a true drug discovery company in the near future, said chairman K Anji Reddy and chief executive officer GV Prasad at the 24th annual general body meeting in Hyderabad on Tuesday.
Domestic pharmaceutical market registered a value growth of 14.4 per cent in January and 9.9 per cent in the 12 months ended January 2009. The yearly turnover was Rs 34,487.17 crore. The growth of the domestic drug sector, which was just 6.8 per cent in November 2008, improved to 13.2 per cent in December and to 14.4 per cent this January.
PharmaSecure, a US based company, is in talks with Indian drug majors to implement a new, cost-effective, SMS-based technology that would allow consumers to check the authenticity of the drug - in a strip, tablet or a bottle - by directly getting in touch with the manufacturer.
Drug Controller General G N Singh said the regulator is addressing all the pending issues to liberate the pharma sector and to simplify export regulations which will be reflected in the forthcoming policy.
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Legal experts and official sources said the alleged submission of fake documents can also lead to criminal charges against Novartis.
The initiative will include special training for Customs and drug regulatory officials to identify spurious drugs, their origin, distribution chain and follow-up action to raid premises and book culprits, in coordination with regulatory and police officials of various countries.
Pharma majors are collaborating with foreign companies to develop newer drugs.
Drug-maker Ranbaxy Laboratories on Thursday said it has received the US health regulator's approval to market Quinapril Hydrochloride and Hydrochlorothiazide tablets, used in treatment of high blood pressure, in different strengths in America.
With China expected to reopen several hundred bulk drug units after the Olympics, prices of some key bulk drugs, including penicillin and paracetamol, have crashed in the Indian market.
The Maharashtra Food and Drugs Administration has initiated action against manufacturers of medicines and instruments, newspapers, TV channels and cable operators making outrageous claims through advertisements.
Aurobindo Pharma on Monday said it has received a tentative new drug approval from USFDA for its fixed dose combination product used for treating HIV-1 infection.
The non-branded generic drugs (sold under chemical names such as cetrizene, omeprazole and nimusulide), which constitute about 8 per cent of the Rs 30,000 crore (Rs 300 billion) Indian pharmaceutical market, is currently not subjected to any such margin cap and according to a study done by the department some of them such are even sold at a margin as high as 1,000 per cent in the market.
Merck arm sues Sun over cancer drugSchering Corporation, part of multinational pharma company Merck & Co, and London-based Cancer Research Technology Ltd have sued Sun Pharmaceutical for allegedly infringing patent rights on the world's largest selling brain cancer drug, Temodar.
Over 550,000 small drug retailers in the country are transforming into producers and marketers of pharmaceutical products, readying to compete with companies such as Ranbaxy, Cipla, Sun Pharma and Lupin whose produce they sell.
