Leading drug firms Aurobindo Pharma, Sun Pharma and Jubilant are recalling different products in the US market for various reasons, as per the latest enforcement report by the US Food and Drug Administration (USFDA). While Aurobindo Pharma is recalling Cyanocobalamin Injection, which is used to treat and prevent lack of vitamin B12, Mumbai-based Sun Pharma is recalling a drug used to increase the production of natural tears in eyes. Similarly, Jubilant Cadista is recalling a drug which is used to treat different inflammatory conditions.
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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.
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.
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.
Cheap bulk drug imports from China may soon post a threat to the Rs 20,000 crore (Rs 200 billion) domestic bulk drug industry.
Most foreign drug makers have 100% subsidiaries in India, apart from their listed arms.
Legal experts and official sources said the alleged submission of fake documents can also lead to criminal charges against Novartis.
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.
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.
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.
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.
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.
'We need to prove to the world that quality vaccines and R&D are possible in India.'
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.
The Drug (Prices Control) Order implemented in May last year brought into its purview 652 packs of 348 formulations.
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.
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.
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.
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 United States Food and Drug Administration has issued a warning letter to it for manufacturing practice violations at its Cranbury facility in New Jersey.
There are also lingering concerns over the culture of misuse of pharmaceutical products in India, which has, in the past, led to other drugs becoming increasingly ineffective.
Drug maker Sun Pharmaceutical Industries on Thursday said it has received the US health regulator's nod for marketing a generic version of the Keppra injection, used for treating epilepsy, in the American market.
The World Health Organisation has excluded two generic antiretroviral drugs of Cipla from its list of approved HIV medicines used more often in poor countries.
Even as India is fast turning into the diabetes capital of the world, multinational drug companies are busy patenting new-generation diabetes medicines for exclusive marketing rights in the country.
With intermittent disruptions in the supply chain of raw materials from China, the Indian pharma industry has braced itself with bigger inventory. Even smaller drug makers are now carrying a month of buffer stock of key raw materials, said industry insiders. The lockdown in various Chinese provinces, including Shanghai, is likely to delay shipments by two weeks to a month, said domestic players. Shipments are critical for the Indian drug industry, which imports 70 per cent of its raw material from China.
FDA had also issued warning letters to Ranbaxy's Paonta Sahib and Dewas facilities as it found extensive problems and deviations from manufacturing norms.
DCGI, health ministry initiate dialogues with foreign regulators, try to understand global best practices
Insurers may be burning their fingers in urban health portfolios for some time now, but the government's rural healthcare initiatives, including its decision to provide free generic drugs to public hospitals, are set to offer fresh avenues of growth for them.
Pharmaceutical and biotechnology major, Wockhardt has received final approval from the United States Food & Drug Administration for marketing the cardiac drug.
Drug maker Cipla always fought a lone battle to make drugs affordable in India.
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