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| Latest In Medicine |
 National Regulatory Authority of India meets WHO standards
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The National Regulatory Authority of India (NRA) and its affiliated institutions now meet WHO efficacy indicators for a functional vaccine regulatory system, after a WHO team of international experts from eight countries conducted its comprehensive review in December last. This has paved the way for easy export of vaccines produced in the country.
India's Rs 19,000-crore vaccine industry accounts for exports worth 13 billion US dollars to 150 countries. India is a major vaccine producer that has 12 major vaccine manufacturing facilities. In 2012, India had seven vaccine manufacturers producing 67 prequalified vaccines (dosage forms). Currently 16 vaccines are prequalified by WHO and exported through United Nations agencies. More than 70 per cent of all measles vaccines used globally are produced in India. The WHO assessment of a regulatory authority as functional means the country's vaccine production lines are efficacious and safe and can easily be trusted. |
| Ranbaxy and Cipla praised get Bill Clinton for their fight against AIDS
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Former US president Bill Clinton praised Indian generic drug companies such as Ranbaxy and Cipla for their stellar contribution in the fight against the HIV/AIDS scourge, saying their cheap drugs saved millions of lives. He said the cheap generics of Cipla and Ranbaxy came in handy when his Clinton Foundation was leading efforts to treat AIDS patients in the Caribbean more than 10 years ago. "I told myself that never again will I come to India without saying a thank you”. The event was Kotak Mahindra's inaugural lecture series in Mumbai. More than 10 years ago, drug maker Cipla sharply cut prices of generic anti-HIV medicines, dramatically transforming the fight against the dreaded disease. Cipla's prices were considerably cheaper than the patented drugs sold by multinationals, pushing many governments of poorer countries in Africa and Asia to adopt generics to treat AIDS patients. Clinton's remarks come a few weeks after the Supreme Court reinforced the primacy of generics in the fight against life-threatening diseases by refusing to grant a patent to Novartis' blood cancer-busting drug Glivec. Clinton cautioned against the current global economic model which favoured capital over labour and rewarded people for their ideas, innovation and entrepreneurship. Sometimes, this creates too much inequality, which is a severe constraint to growth. |
| Dr Reddy's Laboratories recalls muscle relaxant drug from US market
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Dr Reddy's Laboratories has initiated recall of its tizanidine tablets, used as a muscle relaxant, from the US market due to labelling issues.
According to a notification issued by United States Food and Drug Administration, the recall has been initiated voluntarily by the drug maker and the same was intimated to the drug regulator through a letter on March 19. Tizanidine is a drug that is used as a muscle relaxant and used to treat spasms, cramping and tightness of muscles caused by medical problems such as multiple sclerosis, spastic diplegia, back pain or certain other injuries to the spine or central nervous system. "Labelling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details," the FDA notification said. Over 117,000 bottles (150-count tablets per bottle) are being recalled from the market by Dr Reddy's Laboratories under a Class-III recall. The tablets are of 4 mg strength. According to FDA, a Class-III recall is done in a situation in which "use of or exposure to a violative product is not likely to cause adverse health consequences". |
| ICRA says the outlook for pharma companies is positive
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Pharma companies will continue to benefit from recovery in the domestic market and strong growth potential in generics market in developed countries though pricing policy would have near-term impact, a report by credit rating agency ICRA said.
Painting a favourable picture for the domestic pharmaceutical companies, ICRA said balance sheets of major pharmaceutical companies remain strong and provide adequate room for fund raising if required.
Aided by strong growth from US generics business, increasing footprint in new territories and currency tailwinds, ICRA's coverage group comprising of 23 companies with diverse business models witnessed a growth of 22 percent in revenues during the first nine months of the fiscal and relatively stable EBITDA margins.
Overall, margin pressures were limited to a few companies and lack of new product introductions in the US resulting in lower gross margins, higher R&D costs and one-time charge related Generic Drug User Fee Act (GDUFA) pay-out were the most common factors. The government's pro-generic initiatives may not impact the industry structure at least in the medium-term, the ICRA report said. Challenges in its execution, budgetary constraints, lack of resources to effectively monitor quality across manufacturing chain and a market that is predominantly self-paying in nature and largely physician-influenced, make a meaningful shift in favour of 'pure generics' unlikely, it said. The growth prospects for Indian companies would benefit from sizable generic opportunity as drugs with brand value of $ 80 billion are expected to face generic competition over the next 4-5 years. The strong pipeline of ANDAs pending approval, with high proportion of complex generics incrementally and market share improvement given the relatively small base also expected to benefit the industry. Pricing pressures in wake of health care reforms and changing market dynamics have largely offset the impact of expanding product portfolio and geographic footprint for companies in Europe. A relook at business strategies appears to be therefore a common theme with focus on expanding presence in relatively under-penetrated markets namely France, Spain and Italy, branded generic markets in East Europe and niche areas like complex generics and OTCs. However, a positive rupee depreciation impacted earnings of companies with debt profile skewed in favour of foreign exchange borrowings. |
| Glenmark's response soughted by Delhi High Court on US drug giant MSD's appeal
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The Delhi High Court asked Mumbai-based Glenmark Pharma to respond to US drug giant Merck Sharp and Dohme's (MSD's) appeal against the single judge bench order refusing to bar the Indian drug maker from manufacturing and selling anti-diabetes drugs Zita and Zita-Met. Justice S Ravindra Bhat and SK Mishra issued a notice to Glenmark and sought its reply by May 22 on the US firm's plea challenging the single judge order of Delhi High Court. Earlier this month, MSD sued Glenmark alleging that two of its recently launched anti-diabetes drugs infringe on the American firm's patent coverage of Januvia and Janumet. Earlier, a Delhi High Court single judge bench, in an interim order, refused to restrain the Indian company from manufacturing and selling its anti- diabetes medicines. However, the order directed Glenmark to diligently keep record of the production and sales of these drugs and to file the same before this court. The court has kept the US firm's main petition pending for filing of evidence. Subsequent legal proceedings on that account would continue before the Delhi High Court. The order came four days after the Supreme Court denied patent to Swiss innovator firm Novartis on its anti-leukaemia drug Glivec. While MSD's diabetes drugs cost around Rs 43 per tablet (both 50 mg and 100 mg), Glenmark has priced its version at Rs 29 per tablet, said an industry source. But unlike other drug patent wars in India, price differential between innovator MNC's drug brand and generic version is not central to this case. |