In 2009, about 5% of drugs on the market were substandard, while spurious drugs were twice as high as current levels. The incidence of substandard medicine in India has come down substantially in the last five years, findings of a latest study show.
The National Pharmaceutical Pricing Authority (NPPA) has begun scrutiny of such devices, even asking makers to log in every detail about their manufacture and cost. After cardiac stents, about 14 medical devices increasingly sold at inflated prices in hospitals could see price regulation in the months to come. The list includes orthopedic implants, intraocular lenses and artificial heart valves to consumables such as syringes, needles and catheters.
The United States Food and Drug Administration (US FDA) issued a warning letter to Bangalore-based resonance laboratories for filthy manufacturing practices and gave 15 days of time for the company to shape up or ship out.
The prospect of a major change to the regulatory agency comes as drug makers are under fire for high prices, including Marathon Pharmaceuticals LLC, which said "stop" the launch of its drug Duchenne muscular dystrophy after American lawmakers questioned her $ 89,000 a year award.
The Union health ministry said it set "tough" targets to reduce infant and maternal mortality rates, which are already at a faster pace than the global rate.
Among the main concerns of the US pharmacy sector in India are the unpredictable IP environment, high tariffs and drug taxes, failure of regulatory data protection, access policies Discriminatory and non-transparent markets and the unpredictable environment for clinical research.
The National Pharmaceutical Pricing Authority (NPPA) made it mandatory for these facilities to disclose separately the cost of the stent when charging a patient. Medical facilities, including retailers and resellers of stents, should also display the price list of stents on a part of their premises that is easily accessible to anyone wishing to consult the same.
The medical device will soon be disconnected from the pharmaceutical sector so that it can draw a separate and definitive line with a framework facilitating regulatory framework, said Union Minister for Chemicals, Ananth Kumar at Indian Pharma and Indian Medical Devices International Conference in the city.
The cost of a drug eluting stent currently varies between Rs 24,000 and Rs 1.5 lakh and that of a bioresorbable stent is Rs 1.7 lakh to Rs 2 lakh. More than 95% of the stents used in India are drug elution.
The Food Safety and Standards Authority of India (FSSAI) will soon release a draft regulation for organic foods to ensure safety through the value chain through appropriate certification of these products, said a senior official.