Thursday, 27 October 2016

Sun Pharma to acquire Ocular Technologies

Co to pay $40 m to Auven Therapeutics upfront; deal to help pharma major bolster its specialty ophthalmic drugs pipeline

India's largest drug maker Sun Pharma announced it agreed to acquire Ocular Technologies from Auven Therapeutics, a private equity firm focused on accelerated development of breakthrough drugs.

Sun will pay Auven $40 million upfront, contingent development milestones and sales milestones, in addition to royalties on sales of Seciera, a drug used for the treatment of dry eye disease.

Sun is aiming to steadily bolster its specialty ophthalmic drugs pipeline for the global markets, particularly in the US. Its existing pipeline drugs for eye care related diseases in the US include BromSite, DexaSite and Xelpros.

This potential acquisition signifies continued momentum in enhancing our global branded specialty portfolio,” said Dilip Shanghvi, managing director, Sun Pharma.

Seciera is presently in phase three confirmatory clinical trials for dry eye disease that affects 16 million people in the US, according to available data. It is a patented, novel, proprietary formulation and expected to participate in a market that may reach $5 billion by 2020.

It is a clear, preservative-free, aqueous solution. In a completed Phase 2b3 clinical trial in 455 patients, Seciera demonstrated a rapid onset of action and was well tolerated by the study population.

Based on the published data in literature, the efficacy and safety endpoints in these trials compared favourably to other formulations of cyclosporine A.

In a completed Phase 2b3 clinical trial in 455 patients, Seciera demonstrated a rapid onset of action and was well tolerated by the study population. Based on the published data in literature, the efficacy and safety endpoints in these trials compared favourably to other formulations of cyclosporine A” a company statement said.

Dr Reddy's signs strategic deal with Gland Pharma

Hyderabad-based Dr Reddy's Laboratories Ltd on Wednesday said that it had entered into a strategic collaboration with Gland Pharma, a globally recognized developer and manufacturer of sterile dosage forms, to market and distribute a diverse portfolio of eight injectable Abbreviated New Drug Applications (ANDAs) in the US market.

The portfolio is a mix of filed ANDAs pending approval by the US Food and Drug Administration (USFDA) and ANDAs that will be filed imminently, and comprised of generic injectables administered in hospitals and clinics in the US. The combined sale of branded and generic versions of the products in the US is nearly $1 billion for the most recent 12 months ending August 2016, according to IMS Health.

"Dr Reddy's Laboratories has a strong track record in developing, marketing and distributing generic injectables in the US. Our strengths, combined with Gland's track record of manufacturing and operational excellence, will help bring affordable medications within reach of patients and complement our specialty injectables offering in the short-to-medium term," said Alok Sonig, Executive Vice President and Head of North America, Dr Reddy's. Srinivas Sadu, Chief Operating Officer, Gland Pharma, hoped that the company’s partnership with Dr Reddy's would continue to grow.

Perrigo looks to sell Indian plant to cut debt

Ireland-based Perrigo Co. Plc is looking for a buyer for its active pharmaceutical ingredients (API) plant at Ambernath in Maharashtra as part of its efforts to reduce mounting debt, three people close to the development said.

The Ambernath plant, which has a capacity to produce 600,000 tonnes of API per annum, is Perrigo’s only manufacturing unit in India. The US Food and Drug Administration-approved plant’s enterprise value is estimated to be around Rs200 crore, according to one of the people who spoke on condition of anonymity.

The plant has been on the block for the last seven to eight months and number of domestic firms are in talks with the management but no deal has been sealed yet, the person added.

Perrigo acquired 85% in the plant from Vedants Drug & Fine Chemicals Pvt. Ltd for $11.5 million in cash in August 2009. It bought the remaining 15% for $7.2 million in cash in 2014.

“Valuations and limited interest in the industry to expand API capacities could be the possible reasons for the delay in the sale of the asset,” the second person said.

Perrigo hasn’t responded to queries that were emailed on 20 October.

In its annual report for 2015, the consumer healthcare and pharmaceutical firm said its indebtedness could adversely affect its ability to operate. As of June end, Perrigo’s long-term debt stood at $5.65 billion.

Our API category is subject to increased price competition from other manufacturers of API located mostly in India, China, and Europe. This competition may result in the loss of API clients and/or decreased profitability,” Perrigo said in the annual report.

In the past one year, a couple of multinational pharmaceutical companies have put up their assets in India for sale.

Sandoz, the generic arm of Switzerland-based Novartis AG, is looking to sell its Turbhe plant in Maharashtra as part of its global plans to optimize the manufacturing network. The plant is expected to be closed by December 2016, according to a company announcement.

Last September, Pfizer Ltd sold its Thane plant to Vidhi Research and Development LLP for Rs178 crore.

Among Indian companies, Torrent Pharmaceuticals Ltd acquired Glochem Industries Ltd’s API manufacturing unit at Visakhapatnam in June this year for an undisclosed amount.

India can eliminate malaria if govt implements its 15-year plan between 2016-2030 properly

A 15-year plan is laid out by the government to eliminate the vector borne epidemic malaria beginning from 2016 to 2030, according to Dr. Amit Sharma, head and structural computation biology, International Genetic Engineering and Biotechnology (IGEB). He is also winner of the Infosys Prize 2015 for Life Science.

The country is a critical channel to be monitored for malaria spread. This is because, currently, malaria is prevalent in India, Sub Saharan Africa, South East Asia, China and parts of Middle East. Another reason is that Chloroquine resistance in South East Asia is migrating to India. There is also resistance to the best discovered drug Artemisinin reported in Mynamar which is 20 km from the Indian border. There is a need to exercise caution, since malaria has defeated many drugs in the past, he added.

The total elimination of malaria in India is a reasonably achievable goal. The control of this disease is not just with drugs, but public awareness, economic development, use of preventive methods like spraying insecticides, mosquito nets and a concerted effort to create a hygienic environment. “We are confident that if this is implemented properly, we could achieve the goal. Malaria can be controlled and tracked down with political will,” he said.

Dr. Sharma, was in Bengaluru for the Infosys Prize Lecture at National Centre of Biological Sciences (NCBS) to address on ‘Malaria: A biomarker for national development’, said that next big solution for the control of this disease will come from drugs and not vaccines. India is resource-limited and should go forward with a state-specific strategy to control the spread. This will enable elimination of pockets of disease concentration.

Malaria is endemic and causing an epidemic. With global warming, there will be an increase in the incidence of malaria, noted Dr. Sharma.

Giving a global perspective about the disease, he said malaria can be fully controlled. Between 2000 and 2015, there has been a 40 per cent decrease in transmission and 60 percent fall in fatalities. In 1900, the whole world was affected by malaria. Today, around 15 to 20 nations are joining the club of countries where malaria is eliminated. These include Azerbaijan, Georgia, Iran, Kyrgyzstan, Malaysia and Mexico. These countries have been able to achieve 1 malaria case per 1,000 inhabitants. India has not maintained any records of malaria incidence. But Sri Lanka in South Asia serves a great example as a malaria-free country.

In order to effectively get rid of malaria, the need of the hour is to seek to destroy both the parasite and mosquito, besides administering the Artemisinin-based combination treatment to reduce the transmission of infection. Further, mobile clinics, community engagements, education and reliance on insecticides will support elimination of the disease, he said adding that the IGEB has a drug candidate ready for pre-clinical study and is a single dose clearance of all parasites.

Wednesday, 26 October 2016

Indian pharma to take on Chinese imports of critical drugs

Apex pharma exports body Pharmaceuticals Export Promotion Council of India (Pharmexcil) is in talks with the Union government to secure manufacturing of top 100 drugs, many of which are are being imported from China.

Apex pharma exports body Pharmaceuticals Export Promotion Council of India (Pharmexcil) is in talks with the Union government to secure manufacturing of top 100 drugs, many of which are are being imported from China.

"We have requested the government to take steps to facilitate manufacturing of top 100 products that are being imported from China. Currently, we import over $3 billion worthof pharma products from China," Pharmexcil chairman and Aurobindo Pharma director M Madan Mohan Reddy said.

He said a major challenge in securing manufacturing of these drugs in India is that Chinese manufacturers operate on a larger scale, which makes them more viable. Speaking about other challenges, he said that the Indian pharma industry is reeling under a massive shortage of skilled manpower. "As an industry, we are struggling with the issue of availability of skilled manpower. In fact, the attrition rate is very high, ranging between 12 to 15% while ideally it should be around 6-7%," he added.

Hyderabad based pharmaceutical majors blamed for increasing drug resistance

With possible far-reaching consequences for the pharmaceutical industry in India, a report from a European agency campaigning for the environment has blamed manufactures in Hyderabad for growing antibiotic resistance in the world.

Titled ‘Superbugs in the Supply Chain’, the report by London-based Changing Markets Foundation aims to show how effluents from pharma majors, including Aurobindo, Hetero and Mylan based in Hyderabad, besides drug-producing units from other parts of the country, are polluting the environment with drugs that in turn are driving drug resistance at a global scale. The report claims findings of antibiotic-resistant bacteria in effluent samples tested at 14 sites in and around Hyderabad in addition to sample testing in New Delhi, Chennai and Vishakhapatnam.

According to the report, sample testing outside one of Aurobindo’s production units in Polepally, about 80 km from Hyderabad, showed 70 percent of E.coli bacterial colonies in the samples were resistant to cephalosporin (Cefepime, Cefpodoxime, Ceftazidime, Ceftotaxime) fluroquinolones (Ciprofloxacin) and also carbapenem (Ertapenem), which is often used as last resort antibiotics to control infections.

The report also points to high levels of resistant bacteria in Hussainsagar located in the heart of Hyderabad, in a sewage treatment plant located in Amberpet where incidentally vaccine-derived polio virus was found twice this year, and in the Musi river at Edulabad, which is to the east of the city.

Researchers also tested samples collected from five locations in Chennai, two in Vishakhapatnam and two in New Delhi.

Out of these nine locations, testing at three locations - in the vicinity of Hetero Drugs in Rajiyapeta in Chennai, Orchid Chemicals Alathur in Vishakhapatnam and Asiatic Drugs and Pharmaceuticals, Bhiwadi in New Delhi, showed presence of resistant E.coli bacteria.

The report, Changing Markets, described the antibiotic supply chain, beginning with raw materials in China, and claimed resistance was being fuelled due to some production practices. The materials are then used in India for producing drugs for export to western markets. The report alleged that major pharma companies in the US had ties with companies in India and China which had allegedly flouted environmental norms.

Antibiotic resistance is a major health concern for hospitals in India. In Hyderabad, the case of 13 people losing vision after cataract surgeries earlier this year at the government-run Sarojini Devi Eye Hospital was attributed to infection due to drug-resistant Klebsiella bacteria. 

While releasing the Changing Markets report, the European Public Health Alliance, an NGO alliance that receives funding from European Union, in its press note last Tuesday claimed that 10 millions lives could be lost by 2050 to drug-resistant infections with an accompanying economic losses totalling $ 100 trillion.

“The findings of our report and the initial reactions from British and German health authorities demonstrate that polluting practices of pharmaceutical factories in India are no longer going to be tolerated,” said Nusa Urbancic, Campaigns Director at Changing Markets. “In the light of the AMR threat, actions to address pollution from antibiotics manufacturing need to be taken immediately. These include blacklisting of polluting companies, more transparency on supply chains and greater technology transfers for cleaner production practices and ultimately inclusion of environmental criteria in Good Manufacturing Practices,” Ms. Urbancic added.

When comments on the Changing Markets report were elicited, pharma company representatives called it an effort of ‘vested interests in Europe’ and that they would take legal recourse to counter it.

If our processes were leading to drug resistance, our employees would be first affected by it. The contents of the report are not scientifically proven,” said Jayant Tagore, Managing Director of Synthokem Labs, who also presides over Bulk Drug Manufacturers Association.

Pharma units foresee growth

Banking on patent expiry of several drugs in near future, Indian pharma majors anticipate a growth of about 15 per cent in exports this year.

Pharmexcil, the pharma exports body representing the industry, said here on Tuesday that there were setbacks to growth in pharma industries like shortage of skilled manpower and attrition but growth could be expected given the expiry of patents on drugs. “Several companies have filed dossiers for seeking approvals for exporting drugs the patents of which will expire,” said Madan Mohan Reddy, Chairman of Pharmexcil.

Mr. Reddy and other representatives of other pharma companies said problems like the currency crisis in Venezuela would be dealt with and would not impact the industry severely. Speaking on imports from China, industry representatives said Chinese companies mostly supplied intermediaries and active ingredients for drugs but efforts were being made to ramp up such production capabilities in India.

They also termed reports about drug production causing health and environmental problems an effort to malign the image of drug manufacturers in India. Representatives of pharmaceutical companies also announced commencement of India Pharma Week on November 17.

During the week, the CPhl and P-MEC expo, which was dubbed Asia’s largest pharma event, would see around 1,300 exhibitors showcase their products in Mumbai.

India's drugmakers 'will struggle to meet DSCSA deadlines'

Around half of all India's pharma companies face losing market share in the US because they are unlikely to meet medicine traceability mandates, claims an industry expert.

Arjun Guha Thakurta of Life Science Consulting tells Indian trade journal Pharmabiz that with the deadline for implementation of second phase of US Drug Supply Chain Security Act (DSCSA) just over a year away, drugmakers are struggling to meet the level 3 (site level software and hardware) and level 4 (business logistics systems) requirements.

If that level of non-compliance is evident by the next deadline in November 2017, it will raise a question mark over India's ability to serve the US market - or the ability of the US authorities to enforce compliance without risking drug shortages. As it stands, North America is the destination for more than a quarter of India's pharma exports.

Thakurta says that meeting the 2017 serialization requirements will require Indian drugmakers to implement "a slew of upgrades of existing lines and make additional investments into aggregation lines and reporting software." For smaller manufacturers that is a significant problem, he suggests.

The DSCSA was signed into law by President Obama in November 2013, setting a 10-year deadline to implement an individual package level system to track medicines through the supply chain and allow them to be verified using the unique product identifier.

Phase I came into effect on January 1, 2015, requiring pharma manufacturers and other supply chain actors to start recording transaction histories at the lot level, in either paper or electronic format, but the next phase is considerably more challenging.
From November 27, 2017, serialisation becomes a requirement with drug manufacturers having to add a unique product identifier to each package and homogenous case of a product introduced into commerce.

Manufacturers must provide transaction information, history, and statement in electronic format and respond to trading partner’s request for product identifier information within 24 hours. In November 2018 those requirements will apply to repackagers, a year after that wholesale distributors must comply and in 2020 dispensers such as pharmacies come into scope.

According to Thakurta, unless manufacturers have serialization in place for levels 1-4 they will not be able to respond to the request of wholesalers and repackagers within the stipulated time.

Tuesday, 25 October 2016

R&D spending by pharma companies

A Pharmabiz study of R&D spending by 25 research based Indian pharmaceutical companies reveals that their research expenditure during 2015-16 went up by 24 per cent as compared to the previous year. These 25 companies spent a total amount of Rs 11,710 crore for R&D during 2015-16 as compared to Rs 9,439 crore in the previous year. And on an average these companies are spending more than 7 per cent of their net sales on R&D. In fact the average R&D spending of these companies stood at 7.8 per cent in 2015-16 as against 7.1 in the previous year. Among the 25 companies,
- Sun Pharma, the largest Indian pharmaceutical company, spent the highest amount of Rs.2,303 crore on research during the year.
- Dr Reddy’s Lab spent Rs.1,790 crore.
- Lupin’s R&D expenditure stands at Rs.1,732 crore which is almost 55 per cent more than what the company spent in the previous year.
- Cipla’s R&D spend increased by 22.7 per cent to Rs 1,035 crore during 2015-16 from Rs 844 crore.
Alembic and Ajanta Pharma are the two companies which reported a 100 per cent increase in their R&D spend during 2015-16 over the previous year.
- R&D expenditure of some of the companies such as Ipca Labs, Piramal Healthcare, Venus Remedies, Unichem Labs and Panacea Biotec, however declined during 2015-16 for some unexplained reasons.

As in the case of Indian pharma companies, there has also been a steady rise in the R&D spend by the international companies as well during last year. The 15 top global pharma companies spent over 17 per cent of their net sales for R&D during 2015 according to a recent Pharmabiz study. Despite, such huge investments on R&D, neither international nor Indian companies could bring out any new drug into the market. It is quite evident that increasing expenditure in R&D by the Indian companies during the last few years was to grab a larger share of product approvals for generics from highly regulated markets of the US and Europe. These companies have been focusing on introducing patent expired products that are difficult to formulate and market in these highly regulated countries. Steady increase in the number of approvals for ANDAs the Indian companies are obtaining from the global regulatory authorities is on account of this rising expenditure on R&D. During the first nine months ended September 2016, Indian companies secured US FDA final approvals for 141 ANDAs out of 432 total approvals and tentative approvals for 56 ANDAs out of total of 116 tentative approvals. Such a trend can certainly push up the export of pharmaceutical products from India in the tough markets of the US and Europe. No other country is exporting quality and cheap generic products to these developed markets in such a big scale other than India. And the demand for low priced generics has been steadily rising over the years in these markets. But, totally neglecting new molecular research by international and Indian companies is not a good sign especially when world is witnessing emergence several new diseases and growing resistance to existing drugs. It should be socially binding on managements of pharmaceutical companies to keep a good part of their R&D expenditure for new drug research.

Domestic market revives, but US woes to hit pharma firms’ earnings

Indian firms have stepped up investments in research and development to enhance their product pipeline, especially in the specialty drugs and complex generics space.

The lucrative US drug market has become challenging for Indian companies because of regulatory issues, product pricing pressure and limited number of high-value drug approvals.

Sluggish performance in the US and unfavourable currency movements in emerging markets are expected to weigh on the earnings of local drug makers in the September quarter.

Analysts expect overall sales growth of 7-10% during the quarter, but profits are likely to be under pressure as higher spending on research and development and on remedial measures at manufacturing plants facing compliance issues has squeezed margins.

Indian firms have stepped up investments in research and development to enhance their product pipeline, especially in the specialty drugs and complex generics space.

The manufacturing facilities of various companies, including Sun Pharmaceutical Industries Ltd, Dr. Reddy’s Laboratories Ltd, Lupin Ltd, Cipla Ltd, Cadila Healthcare Ltd, Wockhardt Ltd and Ipca Laboratories Ltd, are under the US Food and Drug Administration’s (US FDA) scanner for violation of good manufacturing practices. These companies are witnessing delays in product approvals in the US.

Companies are also seeing price erosion in base products in the US on account of increased competition and consolidation in the distribution channel, which has enhanced the bargaining power of distributors.

Likely double-digit growth in the domestic market due to improved sales of anti-infective drugs, anti-malarial medicines as well as drugs for chronic diseases during the quarter will be a silver lining for pharmaceutical firms.

Earnings of companies still suffering from US FDA-related issues and dearth of approvals will be subdued, while a few companies that continue to enjoy low competition in high-value products launched in past quarters will perform better, Emkay Global Financial Services said in a report.

Aurobindo Pharma Ltd is set to post robust earnings on the back of 15 product approvals in the US during the quarter, while Lupin may continue to see some benefit from limited competition in its generic of diabetes drug Glumetza and integration of US company Gavis Pharmaceuticals, which it acquired earlier this year. Glenmark Pharmaceuticals Ltd is likely to gain from the improved pace of product approvals in the US and the low base of last year.

Sun Pharmaceutical Industries may see a muted quarter as the limited competition in sales of the generic version of cancer drug Gleevec is likely to be offset by pricing pressure in base business, regulatory issues at its Halol plant in Gujarat, and subdued performance of its subsidiary Taro Pharmaceutical Industries Ltd.

Dr Reddy’s Laboratories is expected to be the laggard among top drug makers because of the absence of product approvals as three of its manufacturing facilities remain under the FDA’s lens. Cadila Healthcare will also bear the brunt of regulatory issues. Meanwhile, the high base of last year may weigh on earnings of Cipla and Torrent Pharmaceuticals Ltd.

While domestic pharmaceutical sector growth is expected to be 10-12% in the current financial year, resolution of compliance issues and good number of product launches in the US will be critical to boost earnings of companies in the coming quarters.

Sun Pharma and Cadila Healthcare have completed their remediation procedures and now await re-inspection from the FDA, whereas Dr Reddy’s and Ipca Laboratories are still undergoing corrective actions and would submit a re-inspection request within the next 6-8 months to the FDA, according to Emkay Global’s report.

We believe the situation will improve substantially in 4QFY17/1QFY18 with US FDA issues getting resolved for most of the companies,” HDFC Securities said in a report.

Centrum Broking said in a report that pharmaceutical companies are moving towards better times as around 35% of generic drug approvals from the US FDA are in favour of Indian companies, which would help them gain market share, and as domestic market may continue to witness good growth.

A ‘sweet’ relief for diabetes patients as drug prices drop to half

The price of diabetes drugs have halved in the past nine months, bringing relief to around millions of diabetics in India.

A new class of medicine — belonging to the gliptin family — has lowered the cost of drugs by 50% in less than a year. Of the 68 million diabetics in India, about 1.85 million are on gliptin therapy to manage their type-2 diabetes.

The price came down from Rs 156 a pack in January to Rs 79 in September, thanks to aggressive pricing by domestic companies.

An average daily price for other diabetes drugs stands at Rs 45 against Rs 5 to Rs 7 for teneligliptin-based drugs, launched last year.

Glenmark launched teneligliptin under the brands Ziten and Zita Plus at a breakthrough price of Rs 19.90 a tablet when most gliptins were priced at around Rs 45.

Today, 30 companies, including Glenmark, Mankind Pharma, Zydus, Eris Life Sciences and Intas, are making about 34 brands of drugs from the teneligliptin molecule.

While most of the gliptins were imported, teneligliptin is the only gliptin to be manufactured in India ... With the launch of this, the daily cost of treatment for gliptin therapy has come down dramatically,” said Glenn Saldanha, chairman, Glenmark Pharmaceuticals.

According to a conservative estimate, a diabetic on gliptin treatment saves more than Rs 9,000 a year on medicine.

Mankind Pharmaceuticals, the maker of diabetes drug Dynaglipt, expects prices to fall further.

We are planning to manufacture this molecule (bulk drug) at our new plant, which is set to start in January. We may see further cost benefits that may allow prices to reduce further,” said RC Juneja, the chief executive officer of Mankind Pharma.

Gliptin therapy is safer, with almost negligible side-effects, experts said. The country’s anti-diabetes market is one of the fastest-growing segments, with a growth rate exceeding 25% at Rs 7,638 crore, says data of the All India Organisation of Chemists and Druggists Association.

Saturday, 22 October 2016

Supreme Court upholds centre’s notification capping retail price of drugs

Supreme Court dismissed appeals filed by pharma companies, including Cipla and Dr. Reddy’s, against a notification issued under the Drugs (Prices Control) Order, 1995

The Supreme Court on Friday upheld a 1995 central government notification fixing the retail price of a drug formulation without first deciding the sale price of a bulk drug used in its manufacture.

In doing so, a bench comprising justices Madan B. Lokur and R.K. Agarwal dismissed appeals filed by pharma companies, including Cipla Ltd and Dr. Reddy’s Laboratories Ltd, against a notification issued under the Drugs (Prices Control) Order, 1995.

The notifications (issued since 1999) are valid and not issued mechanically or without any application of mind,” the court said in its order.

At least six pharma firms had moved various high courts which had stayed the notifications. The apex court transferred these cases to itself in 2005. The pharma companies had alleged that the notifications that capped retail prices of drugs without determining the norms for cost of packaging material were arbitrary and discriminatory.

The government is not under any obligation to redetermine the norms every year for fixing of such prices,” the court said in its order.

The government’s contention was that the pharma companies were overcharging consumers by pricing the drugs beyond the retail price cap under the pretext of packaging costs.

According to the National Pharmaceutical Pricing Authority (NPPA), India’s drug-price regulator, the total amount to be recovered from pharma companies for overcharging between August 1997 and April 2016 stands at Rs4,954 crore. In the same period, NPPA has recovered only Rs387 crore.

One expert said that the court’s decision was a welcome step. “Without going into the details of who’s the guilty party since it’s for the courts to decide, a regulator like NPPA’s ability to enforce regulations expeditiously is extremely important because judicial redressal can take such significant amounts of time. I’d like to believe that this decision will go some way in ensuring NPPA gets its due,” said Muralidharan Nair, partner-life sciences at EY.

As per the information provided by NPPA on its website, it has sent out notices imposing penalties for overcharging of drugs at least 1,280 times to pharmaceutical companies.

There are instances of a single company receiving multiple notices from NPPA for overcharging and for dues owed. So while the figure does not reflect 1,280 unique companies, the fallout of the court’s decision will potentially be on many pharmaceutical companies.

Cipla and Dr. Reddy’s did not respond to emails seeking a response.

Government to announce pharma code soon to curb unethical practices

The government will soon be announcing a marketing code for pharmaceutical companies to curb unethical practices, which will benefit the industry, a senior ministry official said.

"The code will be mandatory, and will be for the growth and development of industry", Sudhansh Pant joint secretary department of pharmaceuticals said at the annual general meeting of Organisation of Pharmaceutical Producers of India (OPPI) on Friday.

Concerned with unethical marketing practices and illegal promotions, the government had last year announced its intentions to announce a code which will be mandatory on the industry. At present, the code is voluntary, with certain companies having indulged in unethical practices like offering freebies, gifts, and exotic trips to doctors and healthcare professionals.

Pant also said that a dedicated venture capital fund with a corpus of Rs 500 crore will be floated to encourage innovation in the industry.

Speaking at the AGM later, Meenakshi Lekhi MP and Supreme Court lawyer, welcomed the industry's initiative in setting up 50 healthcare centres across the country. She urged the industry to work in the area of organ donation, adding "harvesting organs is a fine cause".

Several initiatives have just remained on paper and are not implemented, Lekhi added, leading to the sad state of healthcare in the country.

Earlier Shailesh Ayyangar President OPPI and MD India and VP South Asia, Sanofi said, "We have yet to fix healthcare financing issues, so that the disease burden doesn't impoverish our nation. More than ever, the need of the hour is for all stakeholders to come together to find innovative solutions, and keep our nation healthy".

Later a study 'Development of Health Index of Indian states' by Indian Institute of Management- Ahmedabad was also released at the event. The study shows Maharashtra and Tamil Nadu amongst the best performers while Assam, Uttaranchal and Uttar Pradesh were lowest performers. States like Kerala, Himachal Pradesh, Delhi and J&K performed well.

The states were then divided into three categories of high performers, middling performers and laggards for the purpose of policy directions.

"This report is a first step. With the existing data, we are able to make limited comments on the drivers of changes - which can provide preliminary pointers on where action is required. At this stage, we are able to look at the changes in the underlying variables that may have caused the movement. Moving forward we will be able to provide more granular recommendations", said Prof Arvind Sahay, IIM (A).

Friday, 21 October 2016

Drug-resistant Bacteria Found in Facilities of 3 Pharma Cos

Aurobindo, Orchid Chem & Asiatic sites harbouring superbugs due to poor disposal of pharmaceutical waste, alleges an environment lobby group

Three Indian drug companies have been accused of causing drug resistant bacteria due to their polluting manufacturing practices, according to a report by Changing Markets, an environment lobby group.

The investigation revealed that out of 34 sites tested across India and China, 16 were found to be harbouring bacteria resistant to antibiotics.

The manufacturing sites of Hyderabad-based Aurobindo Pharma, Chennai's Orchid Chemicals and New Delhi-based Asiatic Drugs and Pharmaceuticals were found to be harbouring drug-resistant bacteria due to poor disposal of their pharmaceutical waste.

The report found resistance to three major classes of antibiotics - cephalosporins, carbapenams and fluroquinolones - in four manufacturing sites.

At eight of the sites under investigation, resistance to cephalosporins and floroquinolones was detected. “Global pharmaceutical companies whose role should be to cure sick people and channel resources into the development of new medicines are actually contributing to the spread of drug-resistant infections through pollution at their own production sites or those of their suppliers,” the report titled Superbugs in Supply Chain said.

Aurobindo Pharma, which the report termed as the “worst offender“ when it comes to dumping waste, did not respond to an email query sent by ET till press-time. Asiatic Drugs and Pharmaceuticals was not reachable for comments.

Orchid Chemicals said that the company follows right channels to dispose waste. “We are the first zero-effluent discharge company in India. We recycle all liquids and gases, and dispose solid waste in an authorised way,” said Raghavendra Rao, MD, Orchid Chemicals.

Merck Bets on Hybrid Growth Model in India

German co merges pharma, consumer health businesses here to build scale 

German drug maker Merck has merged its pharmaceuticals and consumer health businesses as part of a major makeover, unique to India, aimed at building scale and ramping up local businesses with a hybrid model.

Merck's ambition is to push its established primary care and vitamins and mineral supplements businesses, alongside new launches from its market-leading fertility and oncology divisions. Its strategy of uniting the two businesses locally runs counter to some global drug makers that have separated the two businesses.

The German drug maker, also known to be the oldest pharmaceutical company in the world and clocked 17% growth on the 12-month MAT from Sept 2015 to Sept2016, is ranked the second fastest growing multinational drug firm after Janssen in India.

“We have brought together the portfolios of what we used to call primary care, mainly vitamins and mineral supplements with the portfolio of our consumer health divisions which have major leading brands. So we are consumerising the primary health portfolio. And that will now represent 70% of our business in India. It is growing very fast and this new approach will be able to capture a very attractive market and much faster.” said Belen Garijo, global CEO at Merck, on her second visit to India in as many years.

In biopharmaceuticals, Merck sells Gonal-F for fertility, Erbitux for cancer and in cardio-metabolic, Concor is a top selling brand. In the consumer health business Merck has grown 20%, with sales of `800 crore last year. Its top brands include Neurobion, Seven Seas, Nasivion and Polybion.

Merck's overall business in India includes, products under life sciences and material sciences. The total sales stood at around `2400 crore last year.

The $16-billion drug maker, with a research collaboration with Pfizer for cancer drugs, is hopeful of launching avelumab (for lung cancer) globally next year & work with regulatory bodies to make the drug available in India. Avelumab received breakthrough status from the US FDA & is undergoing advanced clinical trials in India.

Merck has a busy schedule for new introductions in India in the next two years. By mid-2018, the company may look to bring its fertility technologies. In the neurodegenerative diseases, Merck is likely to add Cladribine in 2018, subject to positive outcome and approvals in the developed markets. In consumer health, Merck said it may launch `Perfect Seven Seven Seas Man' and `Perfect Seven Seven Seas Woman' in 2017.

Merck has a collaboration with Lupin, signed in 2014, to accelerate its general medicine and cardio-metabolic portfolio in emerging markets. Garijo noted the alliance is moving as planned and both two sides want to bring products to market in 2018.