Pharma News, February 2017 Highlights Pill

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  • Delhi High Court gives Biocon, Mylan green light to market blockbuster biosimilar for three cancers drugs
  • Government is set to impose a ceiling of Rs 1,000 on the gift to doctors: In a move to curb the unethical practice of pharma companies seeking to influence doctors and chemists through expensive “gifts”, the government is set to impose a ceiling of Rs 1,000 on the value of such giveaways. The Rs 1,000 cap is considered sufficient for drug manufacturers to offer items intended to ensure brand recall.
  • HIV drugs scarcity : Cipla, the sole producer of lopinavir/ritonavir, a combination HIV drug prescribed for paediatric patients, has stopped manufacturing it over non-clearance of arrears by NACO.
  • Niti Aayog wants axe on homoeopathy, ayurveda bodies: Two new bills look to wind up Central Council of Homoeopathy, Central Council of Indian Medicine.A draft bill suggesting creation of an all-new body to replace the decades old statutory bodies is ready, but a final decision will be taken up by a Niti Aayog vice-chairman Arvind Panagariya-led panel set up to suggest sweeping reforms in the department of Ayush under the health ministry.
  • A new vaccine for malaria is up to 100 per cent effective when assessed at 10 weeks after last dose, according to the results of a clinical trial. The vaccine called Sanaria PfSPZ-CVac. Most of the previous vaccines which have been tried involved the use of individual molecules found in the pathogen. However, they were unable to provide sufficient immunity to the disease.
  • Cipla divests Cipla Agrimed & Cipla Vet animal health business
  • NPPA’s view of drug overpricing upsets industry: Include drugs from some of the leading pharmaceutical companies like Sun Pharma, Cipla, Dr Reddy’s, Alembic, Abbott Healthcare, GlaxoSmithKline among others.
  • CDSCO to go online for all services in six months: The Central Drugs Standard Control Organisation (CDSCO) is set to become paperless within six months with completely shifting its services to online portal Sugam. The agency digitized 60-70 per cent of its services through Sugam portal so far.
  • US Pharma Sector Demands Keeping India In Patent Violator List: Among the key issues of concern for the US pharma sector in India are unpredictable IP environment, high tariffs and taxes on medicines among others.
  • Piramal Enterprises To Demerge Healthcare, Financial Services Businesses
  • Mylan and Biocon win right to sell Herceptin biosim in India: Mylan and Biocon today won a court ruling that said they may sell their Herceptin biosimilar in India where it was first introduced three years ago.
  • Ranbaxy’s Singh brothers must seek permission to sell assets: They have been directed to furnish details of assets to ascertain that they will have enough funds to cover an arbitration award granted to Daiichi Sankyo.
  • Pharma lobby cries foul on GIPC’s poor ranking to India: Global Intellectual Property Centre (GIPC) index on intellectual property (IP) standards once again places India at the among bottom three of 45 countries.
  • National Institute of Biologicals (NIB), outlining the findings of the country’s largest ever drug quality survey, has said that over 90 per cent of nearly 5,000 samples picked up from airports and seaports were from China. The Centre should scale up the production of active ingredients used in drugs to meet the country’s need, a government institute has said after it found that over 95 per cent of the samples examined during a survey were sourced from China.
  • NPPA has sent notices to some hospitals: The National Pharmaceutical Pricing Authority (NPPA) has sent notices to some hospitals in the country asking them to respond to allegations that they are charging heart patients higher prices on cardiac stents than allowed. Prices of stents have been slashed by up to 85 per cent after NPPA capped the most widely used categories of the devices at Rs29,600 on February 14. NPPA has sent a show cause notice to Max Hospital in Saket, Delhi and Nidaan Multispecialty Hospital in Sonepat, Haryana
  • Life-saving Wilson’s disease treatment available in India once again: Months after a reported shortage of the life-saving D-Penicillamine medicine to treat Wilson’s disease, the country’s drug regulator claims it has remedied the problem. The regulator says the shortage occurred due to non-availability of the active pharmaceutical ingredient (API)
  • A sub-committee constituted to examine issues relating to online sale of drug has recommended the creation of a national portal to act as a platform for transacting and monitoring online sale of drugs and evolving a mechanism to register e-pharmacies.
  • OPPI is pushing for replacing state based multiple drug authorities with a single body for more effective protection of intellectual property (IP) and patents. The Organisation of Pharmaceutical Producers of India (OPPI), which represents 22 pharma companies, including Abbott, Pfizer, Novartis, Novo Nordisk and Sanofi, also wants specialised patent courts for fast disposal of patents and IP disputes.
  • The health ministry on Monday moved the Supreme Court challenging a Delhi High Court order that had revoked its ban of over 300 fixed dose combination drugs. The petition comes almost two months after the Delhi HC on December 2 set aside the government notification that had banned hundreds of fixed dose combination (FDC) drugs, or medicines made by combining two drugs into a single dose. The ban had impacted several popular brands including Corex, Phensedyl, Saridon, D’Cold Total and Vicks Action 500 Extra.
  • IPA released guidelines on data reliability: The Indian Pharmaceutical Alliance (IPA), an industry lobby group representing large domestic drug makers, on Thursday released guidelines on data reliability as part of its continuing efforts to help improve the overall standards of the Indian pharmaceutical industry. Allegations of data falsification or manipulation are cited as main reasons by US FDA for pulling up Indian companies as part of its regulatory scrutiny.
  • Pharma and Med Tech Zone to be set up soon at Bengaluru: In a move to boost domestic manufacturing of pharmaceuticals and medical devices in India under the Make in India mission, the government will work to set up a Pharma and Med Tech zone in Bengaluru soon, announced Minister for Chemicals and Fertilizers Ananth Kumar while inaugurating the second edition of the India Pharma & India Medical Device International Conference on Saturday. Deliberations are still underway at the highest levels in the government to make the Department of Pharmaceuticals an independent ministry, he explained.
  • Indian pharma industry voices concerns over constant reduction in the healthcare budget of the Central government and an increasing pressure on price reduction which is resulting in squeezed margins. India spends about 1 percent of its gross domestic product (GDP) on public health, compared to 3 percent in China and 8.3 percent in the United States.

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