Pharma News

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.

CPhI Conferences, a division of UBM India which hosts a number of successful pharmaceutical conferences has announced the 5th Annual Pharma Project Management slated for 16th – 17th March 2017 at The Westin, Mumbai. The Conference is focused on ensuring successful delivery of projects by monitoring risks, cost and time through a unique conference - workshop model. It gathers pharma industry professionals in order to congregate, network, exchange ideas and knowledge and form future alliances.

The Drug Marketing and Manufacturing Association (DMMA) estimates that the nutraceutical industry is expected to experience annual growth of 16% (CAGR) over the next five years. With annual growth of about 20% over the past six years, the market for nutraceuticals in India is expected to double to Rs 26,764 crore by 2020.

At present, NPPA is unable to regulate 350 drugs, which are under the National Essential Drug List (NLEM), in the absence of market data. Therefore, the authority must be empowered by amending the Drug Price Control Order (DPCO) for access to the data.

The government has removed the anomalies in the duty structure to boost the manufacture of medical devices, said Ananth Kumar Minister of Chemicals and fertilizers.  The medical industry had been demanding removal of duty anomalies for many years.

USFDA has now issued the draft regulations to assist potential applicants who plan to develop and submit an abbreviated new drug application (ANDA) to seek approval of a proposed combination product including both a drug and a delivery device.

[adsense:336x280:8701650588]