PHARMA LITERATI

India’s largest drug maker Sun Pharmaceutical Industries Ltd will shut down some of its manufacturing plants in India as well as overseas as the company will continue trimming its large manufacturing base as part of cost optimisation. The decision, which will help the company cutting the entire operating costs of these facilities, is also part of the business integration plan that is in progress at the company, especially after the merger of Ranbaxy Laboratories that it bought in 2014. Though the move will see several layoffs at the shop floor level at all these locations both in India and several other countries, the exact number of jobs that will be affected is not known. The plan to shut down manufacturing facilities is in addition to the company’s strategy to divest non-core units across its markets, said a person close to the development. Sun Pharma has already divested three of its manufacturing units in the US in the last few months. “ The company’s preferred opt...

Centuries ago, Indian princes would bathe in the cool Kazhipally lake in Medak. Now, even the poorest villagers here in India's baking south point to the barren banks and frothy water and say they avoid going anywhere near it. A short drive from the bustling tech hub of Hyderabad, Medak is the heart of India's antibiotics manufacturing business: a district of about 2.5 million that has become one of the world's largest suppliers of cheap drugs to most markets, including the United States. But community activists, researchers and some drug company employees say the presence of more than 300 drug firms, combined with lax oversight and inadequate water treatment, has left lakes and rivers laced with antibiotics, making this a giant Petri dish for anti-microbial resistance. " Resistant bacteria are breeding here and will affect the whole world ," said Kishan Rao, a doctor and activist who has been working in Patancheru, a Medak industrial zone where many dr...

Leading pharma companies last week promised to take concrete actions to combat antimicrobial resistance. The ‘industry roadmap’ sets out four commitments and was signed by 13 companies, including GSK, Johnson & Johnson, Merck and Co., AstraZeneca and Pfizer . It follows on from the Davos Declaration’s call for a sustainable market for antibiotics in January. This is a pretty big step, says Kevin Outterson, a professor of law Boston University in the US. ‘All the leading companies in the antibiotics field [are] agreeing to sell less of their product, making sure there is better access for poor people and being more careful in how it is manufactured,’ he says. Managing pollution The first key commitment is to tackle pollution linked to antibiotic manufacturing. Discharging active ingredients into the environment promotes drug-resistance in microbes, and the companies have agreed to review their practices in controlling the releases of antibiotics. In one study in India, ...

Calling for in-licensing system for patented and monopoly drugs developed abroad, Cipla chairman Y.K. Hamied said the company will continue its efforts to offer patients affordable medicines. Drug companies are facing a tough environment due to the government bringing more products under the price control policy as also tightening of registration procedure that has impacted time to market newer products, Cipla chairman Y.K. Hamied has said. “ The environment for the domestic pharma companies remains challenging with more products coming under price control, and other pressures such as government legislation to ban certain fixed dose combination drugs ,” Hamied told shareholders at the company’s annual general meeting (AGM), as per a regulatory filing on Thursday. Moreover, with the tightening of new product registration procedures, the approval time to market newer products has also been significantly impacted, he added. “ We do hope that the government will look into so...

Alarmed at the disappearance of life saving drug D-Penicillamine from the market, which is used to treat Wilson’s disease, the central drug regulator has called a meeting with five major pharmaceutical companies, which are involved in its sale, on Friday. The five firms which have been requested by Central Drug Standard Control Organisation (CDSCO) to attend the meeting “without fail” are German Remedies, Panacea Biotec, Samarth Lifesciences, VHB Lifesciences and Chandra Bhagat Pharma Private Limited . Wilson’s diseases is a rare genetic disorder which prevents the body from getting rid of extra copper. The build up of copper may damage liver, brain, kidneys and eyes. D-Penicillamine is known to remove excess copper via urine. “ As per the representations (to CDSCO), the drug has disappeared from the market in the recent past and it is no more available in the country. The availability of the drug is very important as there are no alternatives for the treatment of Wilso...

Soon India will have a separate ministry for pharmaceuticals which will specifically deal with the issues pertaining to the pharma industry. " I have requested our Prime Minister Modiji to have an umbrella ministry for the pharma industry. We are hoping that it will be in place in sometime .” " It is a sunrise industry and needs to be set up fast ," Union minister for chemicals and fertilisers Ananth Kumar said. He was speaking at the second edition of Mail Today's Health Conclave. Kumar, who recently attended the BRICS wellness workshop, raised the issue of integrated medicine at the seminar. Emphasising on 3As - authenticity, affordability and availability of medicines - he said that as per the rough estimate, nearly 50 per cent of the Indian population is not consuming 50 per cent of the consumption value. Talking about the government's Jan Aushadi Yojana, he said that more than 400 outlets across the country have been set up so far and by the end o...

Cipla, ranked third in the $17-billion Indian pharmaceutical market after Sun Pharma and Abbott, is setting its eyes on reaching a billion dollar sales mark, backed by new drug launches from its own research labs and a slew of partnerships with multinational and Indian drug firms. On a moving annual total basis, Cipla's India sales rose 8.6% to `5,033 crore in August, according to the AIOCD PharmaTrac data. Its market share stood at 4.9% compared to Sun Pharma's 8.7% and Abbott's 6.23% during the same period. Umang Vohra, the newly designated managing director of Cipla , told ET Now that he hoped the India sales to cross a billion dollar “relatively soon“. Cipla has stepped up launch plans in areas like respiratory, dermatology, cardiovascular and urology, which will help speed up its India growth. Also, several Indian and multinational drug makers have evinced interest in partnering with Cipla, said Vohra, who took over from Subhanu Saxena this month. He...

A strike by Sun Pharma employees this week is just one symptom of a campaign by a prominent trade union to seek more equitable working conditions for pharma sales representatives. The Federation of Medical and Sales Representatives' Associations of India (FMRAI) claims many reps working in India do so with contracts that contravene their working rights--as well as Indian employment law. It is trying to organize a mass demonstration on the streets of the capital, New Delhi, on November 21, and is threatening an all-out national strike if its demands are not met. This week, around 500 Sun Pharma sales reps engaged in a one-day strike to protest what they call unfair treatment of workers who joined the company from Ranbaxy Laboratories, including unpaid wages and expenses, and demotions to a lower working grade. Sun Pharma acquired Ranbaxy in a $3.5 billion deal that closed in March 2015 and created India's largest pharma group. The dissatisfaction with sales rep ...

Just about two years ago, when the Supreme Court had rejected the claims of Bayer against grant of compulsory licence by India Patent Office to the Hyderabad-based Natco Pharma for manufacture and sale of cancer fighting drug Sorafenib at Rs 8,800 per person per year against Rs 33.60 lakh by the multi-national firm, an impression was sought to be created by the global firms as if India was disincentivising research and development (R&D). Such a campaign had solicited help even from the officials from the US or other western nations suggesting India was transgressing the multilateral rules. This was far from truth, because what the India Patent Office had done was well within the rights given by the World Trade Organisation under the TRIPS (Trade Related Intellectual Property Rights) agreement reached at the landmark Doha Round in 2001 with a pivotal role by India’s then commerce minister late Murasoli Maran. At that WTO Ministerial Meeting, India had fought as a champion of the ...

India’s approval and regulatory system for drugs and pharmaceuticals is dysfunctional. A recent report by Dinesh Thakur, Ranbaxy whistle-blower and health activist , points out shortcomings and glaring anomalies in our oversight system for drugs and pharma, which need to be promptly rectified. We have a hugely fragmented drug regulatory framework, with as many as 36 state and Union territory licensing authorities, whereby a pharma manufacturer can garner a licence in one state and distribute its product nationally. It follows that any laxity, say, a batch of Not of Standard Quality (NSQ) drug anywhere can have national and even international repercussions. The report cites studies which show that substandard and NSQ drugs can be as high as a fifth or more of all medicines procured locally. The Central Drugs Standards Control Organisation (CDSCO) and the state authorities are supposed to carry out routine testing of drug samples, but the report finds the statistical methodology ...

Mumbai-based businessmen, Purushottam Agrawal (Founder and Vice-Chirman) and Madhusudan Agrawal (Co-founder) of Ajanta Pharma Ltd, were felicitated by the Pharmaceuticals Export Promotion Council of India (Pharmexcil) as part of the ‘ Pharma CEOs Conclave’ . Anice Joseph Chandra, Director, Ministry of Commerce & Industry, Government of India gave away the honour to the company during ‘12th Annual Meet’ of Pharmexcil. Ajanta Pharma Ltd ., which started operations in 1973 with re-packing of generic products, is one of the leading producers of branded generics and speciality drugs with a turnover of Rs 1,728 crores in the 2015-16. Speaking on the occasion, Purushottam said, “ The Indian Pharma industry’s exports are growing by leaps and bounds and in the coming years, it may become one of the top markets in the world. At this point, being recognised for our work is both an honour and a privilege .” Source: http://www.thehansindia.com/posts/index/Health/2016-09-2...

In an order that will spell relief for diabetic and heart patients, the Bombay high court has refused to stay a July 2014 notification of the National Pharmaceutical Pricing Authority (NPPA) which placed price caps on 108 single-formulation drugs used for cancer, HIV, cardiovascular, and diabetes treatment. The division bench ruled that the government was not exceeding its powers when regulating the prices as these medicines were required to be taken by the “ever increasing number of patients” throughout their life. The Indian Pharmaceutical Alliance (IPA) , a group of pharma companies, had gone to court against the notification pointing out that these drugs did not fall under the “essential” criteria and were not scheduled drugs and therefore not eligible for price control. The IPA had termed the NPPA’s action arbitrary and violative of their fundamental rights. The NPPA notification in July was based on guidelines issued in May that gave the NPPA powers to cap authority under ...

Every week of thousands of patent applications are published in India. The patent applications filed by the pharma academic research institutes in India go un-noticed. We publish a list of Indian applications published related to pharma academics. This would provide us an idea about the kind of academic research being carried out in these institutes. For details of these patents, please write back to us at  pharmaliterati@gmail.com Invention Application number Inventors Institute A novel anti-glycating peptide against diabetes 201611023426A 1) Mohd. Sajid Khan 2) Moniba Rahim Nanomedicine & Nanobiotechnology Lab, Department of Biosciences, Integral University, Lucknow, Uttar Pradesh Self nano emulsifying delivery systems of lurasidone and preparations thereof for oral administration 170/CHE/2015A 1) Vasudha Bakshi 2) Amarachinta Padmanabha Rao...