PHARMA LITERATI

There is some good news for the over 72 million diabetics in India, with a cheaper version of a blockbuster drug hitting the market on December 10. The domestic pharmaceutical market is abuzz with news of over 15-20 companies launching generic versions of the widely-prescribed anti-diabetic drug Vildagliptin , with its price expected to crash by half. The potential of more affordable diabetic care comes in the wake of Swiss major Novartis-owned Vildagliptin losing patent on Monday — a development closely watched for months. Dozens of companies have readied plans to get a slice of the action in the growing Rs 14,000-crore diabetes therapy market, with the number of players expected to cross 50 soon. With the drug’s patent expiry, the price may drop to Rs 6 per tablet over the next few months, from the existing Rs 20-25 each. What makes the patent expiry significant for Indian pharma is that Vildagliptin is the first among the gliptins, a relatively new class of oral diabetes ...

The success of MNCs in terms of their growth rate in the last 18 months. This has to be attributed to the regulatory regime change that has happened in India, says  Amit Rajan , MD,  Prosfora Technologies . Excerpts from an interview with ET NOW . Do you think it is a given that Indians will consume more medicines and MNC companies which have a niche presence in diabetes or vaccine or for that matter thyroid, will continue to grow at inflation plus 5%? Yes, look at the success of MNCs in terms of their growth rate in the last 18 months. This has to be attributed to the regulatory regime change that has happened in India and unlike our own India Inc, which has a problem with the government, MNCs pharma companies to thank the Indian Government. Let me give you three-four regulatory changes that have helped: A) There is s olid patent protection . There is respect for patent now and the courts are not listening. After 2014, there is not a single compulsory licensing t...

Source:  https://qcfi.in/

Source:  https://www.bioethicon.com/                

Source:  http://www.crsic.org/pdf/crs-brochure-for-national-event.pdf  

  Source: https://congress.sperpharma.org

Indian pharma companies now need to increasingly focus on stability studies to prove the safety of formulation till the end of the shelf life. The industry already has three regulations to adhere: Drugs & Cosmetic Rules, US FDA and WHO stability testing guidelines for API, finished drugs and the ICH norms on the same.  The purpose of the stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity and light. It also calls for storage conditions, retest periods and shelf life of the products, said B Kumar, deputy drugs controller, sub-zonal office, CDSCO, Bengaluru. In order to ensure that the drug formulations marketed in the country are stable till the end of the shelf life, it is necessary that stability studies should be brought under the condition of license for manufacturing drugs especially in Rule 71, 71-B & Rule 76, he adde...

What does 2019 have in store for Pharma? It was asked to industry Thought Leaders to name one disruptive trend or technology that will have a significant impact on the market in the year ahead. Will pricing pressure lead to a shift in budget management? Is this the year for biosimilar approvals? Will we see continued M&A activity in the sector? From life cycle management to AI, and Supergenerics to digital healthcare, listed are the Pharma and Biopharma trends about 2019. 1. Big Pharma Restructuring will Create Challenges and Opportunities Jim Miller, Former President & Founder, PharmSource 2. Continued M&A in the CDMO and CMO Business Sector Kevin Bottomley, Partner, Results Healthcare 3. 2019: The Year of AI Gunjan Bhardwaj, CEO, Innoplexus 4. A Paradigm Shift in the Management of Pharmaceutical Budgets Maarten Van Baelen, Market Access Director, Medicines for Europe 5. Value Added Medicines: Digital Heal...

The Indian pharma is not the space to look at when discussing job creation in the country over the past four years. The sector, where the bulk of major players look to the US as the biggest market to drive revenues, is coping with its unique challenges in the market. Multiple factors have contributed to the cost pressures faced by leading players in the sector. For instance, channel consolidation (acquisition and merger between wholesalers and chains sourcing generic drugs) has given them tremendous bargaining power that raises the prices of drugs. There is also  the dimension of increased competition with new entrants joining in to tap the same market. In fact, many Indian companies are today competing with each other on the US soil.  Then, there is also the component of regulatory overhang, with some of the companies being pulled up by the US drug regulator and import alerts being imposed impacting the future supply plans of some of the companies. Though some are ge...

  Although exports account for only 50 per cent of revenue for the domestic pharma industry, its contribution at the operating profit is higher owing to relatively superior profitability of products sold in regulated markets and that the hemorrhage over the past two years can be pinned squarely on dwindling exports to regulated markets. After a bruising two year, the domestic pharmaceutical sector is set for a sharp turnaround in the new fiscal year with a 20-22 per cent growth in operating profit - the fastest pace since 2014, while revenue may grow at 9-11 per cent, according to a report. "The projected good run is premised on a decline in regulatory alerts for larger companies as well as a bigger pipeline of high-value drugs compared to the past two years. Operating income and profit will see a course reversal with a 20-22 per cent growth, while revenue may clip at 9-11 per cent," rating agency Crisil said in a report. This will be primarily on the back of stro...

The Rs 3600 crore acquisition of Unichem's domestic business by Torrent Pharma has brought the mojo back into India pharma's merger and acquisition scene, which was eluding large deals in the past few years. Concerns related to the US market, which contributes major revenues for most of the leading firms, increasing regulatory concerns and price controls in the domestic market were forcing drug majors to be cautious in jumping into big deals. The struggle of leader Sun Pharma to digest its biggest acquisition, Ranbaxy Laboratories, also made drug firms cautious in executing large M&As. Sun and Ranbaxy had merged in February 2015 in a cashless share transaction worth $3.2 billion, after an year of announcing the deal. Thereafter Indian pharma was not witnessing any large mergers. Indian drug firms' domestic business was always an attraction for multinationals to get a footprint in India. In the largest ever transaction so far, Ajay Piramal had sold his formula...

We have received the information related to firing of 100 people from R & D of Lupin Pharma via social medias. We could not confirm the news officially. But, we are trying to confirm the news as well as the number of employees with their departments. As per the social media reports, it includes people from drug discovery unit from executive to vice president level. If the news is correct, it would be really a sad day for the pharma job market in India especially for those in the discovery arena. Comments are welcome. Disclaimer: Pharma Literati does not hold any responsibility regarding the authenticity of the news and this is mere for the information of the students and the readers.

A day-long meet on draft pharmaceutical policy is called by department of pharmaceuticals (DoP) on August 30 in New Delhi to discuss key aspects of the policy with representative bodies of pharmaceutical industry and trade. Representatives from IPA, IDMA, BDMA, FOPE, OPPI, CIPI, FICCI, ASSOCHAM, CII, PHD, Pharmexcil, AIDAN, Nathealth, Prayas, Consumer Connexion, LOCOST, JSA, AIOCD, AICDF, Consumer India have been invited for the conference. The inaugural session of the  meet will be addressed by Sudhansh Pant, joint secretary of DoP, Jai Priye Prakash, secretary of DoP, CK Mishra, secretary of ministry of health and family welfare, Ramesh Abhishek, secretary of department of industrial policy and promotion, Rita Teaotia, secretary, department of commerce, Ajay Narayan Jha, secretary, ministry of environment, forests and climate change, Bhpendra Singh, chairman of National Pharmaceutical Pricing Authority, Rajneesh Tingal, joint secretary of DoP. Divided into four sess...

The prices of medicines will soon bend in the service to the government’s ‘ease of doing business’ and ‘Make in India’ programmes, if the proposals in the Draft Pharmaceutical Policy, 2017 are accepted. The Draft Policy, which BusinessLine has seen, calls for ‘re-orientation’ of the Drug Price Control Order (DPCO) from “price-control to monitoring of drug prices”. The Draft, which focuses heavily on prices of medicine, has proposed massive dilutions in the existing framework, which would give more control to the government over the operations of the National Pharmaceutical Pricing Authority (NPPA), which till now functions as an autonomous body. It also attempts to strip the NPPA of some powers, for instance, once the price for a drug is fixed the pricing authority would not be allowed to revise them. The NPPA would also lose its power to cap the prices of in-patent medicines, and would be able to use its “emergency powers” only on the government’s orders. “This Polic...