Friday, 30 September 2016

Sun Pharma To Shut Some Plants In India, Overseas


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 option is to divest non-core manufacturing units, so that the employment at these sites would remain unaffected as it would be run by the new owner. But, it may not work always. So, in such cases, it has no option but to shut down,” confirmed a senior executive from Sun Pharma.

While the company is still struggling with some of the Ranbaxy units due to serious regulatory compliance issues raised by US FDA sometime ago, the plants that it wants to shut down as part the rationalisation would be mostly from its own side, said the person quoted above.

Sun Pharma had earlier indicated that based on the optimum level of manufacturing infrastructure, for current and future business requirement, it will look at rationalizing manufacturing footprint. The Indian generic drug maker, which currently operates in several markets including India, US, Europe and many other emerging markets, had owned some 30 manufacturing units and at least 30,000 employees when it formally merged the troubled Ranbaxy Lab within it in March 2015.

It sold one of its manufacturing units in the US to Nostrum Laboratories Inc for an undisclosed sum in 2015 as part of this manufacturing rationalisation. Following this, the company also sold two of its production units -- located at Philadelphia and Aurora along with 15 related pharmaceutical products to Frontida BioPharm Inc in June.

The Dilip Shangvi-promoted drug maker has some of its key manufacturing plants in India under the US FDA scanner as the regulator had raised compliance issues. These affected manufacturing sites-- located at Halol and Karkhadi in Gujarat, are originally belonged to Sun Pharma. While, the other units located at Dewas in Madhya Pradesh, Poanta Sahib in Himachal Pradesh and Mohali in Punjab were inherited through the Ranbaxy acquisition.

While the Halol manufacturing unit, which is critical to Sun Pharma’s overall sales and revenue, is currently awaiting a re-inspection by the US regulator, the other units are still under remediation process and the issues would continue impacting the sales for more time.

The cost of cheap drugs? Toxic Hyderabad lake is 'superbug hotspot'


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 drug manufacturers have bases, for more than two decades.

Drugmakers in Medak, including large Indian firms Dr Reddy's Laboratories Ltd, Aurobindo Pharma Ltd and Hetero Drugs Ltd, and U.S. giant Mylan Inc, say they comply with local environmental rules and do not discharge effluent into waterways.

National and local government are divided on the scale of the problem.

While the Central Pollution Control Board (PCB) in New Delhi categorizes Medak's Patancheru area as "critically polluted", the state PCB says its own monitoring shows the situation has improved.

The rise of drug-resistant "superbugs" is a growing threat to modern medicine, with the emergence in the past year of infections resistant to even last-resort antibiotics. In the United States alone, antibiotic-resistant bacteria cause 2 million serious infections and 23,000 deaths annually, according to health officials. Thirteen leading drugmakers promised last week to clean up pollution from factories making antibiotics as part of a drive to fight the rise of drug-resistant superbugs, while United Nations member countries pledged for the first time to take steps to tackle the threat.

Major Earner
Patancheru is one of the main pharmaceutical manufacturing hubs in Telangana state, where the sector accounts for around 30 percent of GDP, according to commerce ministry data. Drug exports from state capital Hyderabad are worth around $14 billion annually.

Local doctor Rao pointed to studies by scientists from Sweden's University of Gothenburg that have found very high levels of pharmaceutical pollution in and around Kazhipally lake, along with the presence of antibiotic-resistant genes.

The scientists have been publishing research on pollution in the area for nearly a decade. Their first study, in 2007, said antibiotic concentrations in effluent from a treatment plant used by drug factories were higher than would be expected in the blood of patients undergoing a course of treatment. That effluent was discharged into local lakes and rivers, they said.

"The polluted lakes harboured considerably higher proportions of ciprofloxacin-resistant and sulfamethoxazole-resistant bacteria than did other Indian and Swedish lakes included for comparison," said their latest report, in 2015, referring to the generic names of two widely used antibiotics.

Those findings are disputed by local government officials and industry representatives.

The Hyderabad-based Bulk Drug Manufacturers Association of India (BDMAI) said the state pollution control board had found no antibiotics in its own study of water in Kazhipally lake. The state PCB did not provide a copy of this report, despite several requests from Reuters.

"I have not seen any credible report that says that the drugs are no longer there," Joakim Larsson, a professor of environmental pharmacology at the University of Gothenburg who led the first Swedish study and took part in the others, told Reuters by email. "There might very well have been improvements, but without data, I do not know."

Water Treatment
Local activists and researchers say the Common Effluent Treatment Plant (CETP) built in Medak in the 1990s was ill-equipped to handle large volumes of pharmaceutical waste. After protests and court cases brought by local villagers a 20-km (12-mile) pipeline was built to take effluent to another plant near Hyderabad. But activists say that merely diverted the problem - waste sent there, they say, mixes with domestic sewage before the treated effluent is discharged into the Musi river.

A study published this year by researchers from the Indian Institute of Technology, Hyderabad, found very high levels of broad-spectrum antibiotics in the Musi, a tributary of the Krishna, one of India's longest rivers.

Local government officials responsible for the plants did not respond to Reuters' requests for comment.

Nearly a dozen current and former officials from companies producing medicines in Patancheru told Reuters that factory staff from various firms often illegally dump untreated chemical effluent into boreholes inside plants, or even directly into local water bodies at night.

All the officials spoke on condition of anonymity and Reuters was unable to independently verify those allegations. Major manufacturers in the area, including Dr Reddy's and Mylan, said they operated so-called zero liquid discharge (ZLD) technology and processed waste onsite.

"Mylan is not dumping any effluent into the environment, borewells or the CETP," said spokeswoman Nina Devlin.

Dr Reddy's said it recycled water onsite and complied with all environmental regulations.

The same industry officials who spoke to Reuters said the pollution control board rarely checked waste-treatment practices at factories, adding that penalties for breaches were meager.

The Telangana state government did not respond to requests for comment.

"We are aware some companies are releasing more than the allowed effluent, but they are profit-making companies," said state PCB spokesman N. Raveendher. "We do try and take action against the offenders, but we cannot kill the industry also."

Many smaller companies also lacked the funds to install expensive machinery for treating waste, he added.

Court Battles
A series of local court cases have been filed stretching back two decades, accusing drug companies of pollution and local authorities of poor checks. In some cases, companies have been ordered to pay annual compensation to villagers, but many are still grinding through India's tortuous legal system.

Wahab Ahmed, 50, owns five acres of land near the shores of Kazhipally lake, where he grew rice until a decade ago. He says the worsening industrial pollution from several nearby pharmaceutical factories left his land barren.

"We have protested, sued, and done all sorts of things over the years ... that's how some of us are now getting around 1,700 rupees (roughly $20) a year from the companies," he said. "But what can you do with that small sum today?"

More than 200 companies were named as respondents in the case he was referring to, filed by a non-profit organization on behalf of villagers. While pollution of farmland is a serious problem for villagers who depend on it for their livelihood, the potential incubation of "superbugs" in Medak's waterways has wider implications. The risk is that resistant bacteria would then infect people and be spread by travel.

So far, most of the focus worldwide on antimicrobial resistance has been on over-use of drugs in human medicine and farming. "Pollution from antibiotic factories is a third big factor in causing antimicrobial resistance," the chairman of one of the world's largest drugmakers told Reuters. "But it is largely overlooked."

Pharma giants commit to tackling antimicrobial resistance


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, effluent from a treatment plant contained the antibiotic ciprofloxacin in concentrations as high as 31 mg/L, around a million times higher than levels in regular treated sewage effluent.

This happens partly because its legal and it is not so costly to lose some compounds, says Joakim Larsson, environmental pharmacologist at Gothenburg University. ‘When it comes to discharges of pharmaceuticals, there are no good regulations in China or India or in Europe or the US,’ he adds. Good antibiotic stewardship can entail trade-offs between benefits in patients and risks to society, but antibiotic pollution just gives some cost savings.

This is something completely within industry’s control and we need to sort it out. And this roadmap says we are going to make it happen,’ says James Anderson, director of external partnerships at GSK. He says GSK is comfortable that its own API [active pharmaceutical ingredient] factories do not discharge high levels of waste, but is rolling out a new audit process to external suppliers. This will be completed next year. There is also a trade association to improve supply chains.

It is hard to know how companies perform in pollution. Many rely on contractors in India and China to produce APIs. ‘Industry does not self-report on discharges in terms of antibiotics,’ says Larsson. He believes incentives from outside are also needed. He views generic substitution strategies pursued by governments in Europe as part of the problem because the lowest cost antibiotic is subsidised. ‘If the state says only price matters, then they ignore those who try to improve the pollution situation. Why should companies increase their costs?’

He points to one strategy recently adopted by Swedish hospitals: to ask for certain qualities in terms of manufacture, including emissions. Anderson strongly agrees. ‘Industry driving itself forward and purchasers starting to request clarity: that will make a real difference in the next few years.’ The roadmap sets a target to have a common framework for managing discharge by 2018. Industry argues that it still has to develop a scientific understanding of what constitutes acceptable minimums.

Others welcome a self-regulatory approach by industry, with provisos. ‘There are benefits to self-regulation. It’s less bureaucratic and a company might introduce different models, but it needs accountability and good monitoring,’ says John-Arne Rottingen, infectious disease expert at the Norwegian Institute of Public Health. He adds antibiotics should have a full list of ingredients, detailing where and when they are produced.

Prescription problems
 The second commitment is to ensure antibiotics are used only by those who need them, which the signatory companies have promised to examine by the end of 2017. Potential strategies include the removal of incentives to sell more antibiotics, as well as working to reduce uncontrolled purchases such as over-the-counter and internet sales.

There is a long history of various companies over the decades aggressively selling antibiotics all over the world. They were treated as cheap and easy to replace,’ says Outterson. ‘This is the first time industry has said collectively said we need to prioritise stewardship and reduce sales.’

GSK has already de-linked pay with sales volumes for all its drugs. ‘We now reward our sales reps based on technical knowledge and feedback from doctors, rather than sales volumes, which is the typical mechanism,’ says Anderson. This was brought in globally at the beginning of this year.

Industry has so far not recognised antibiotics as different, but in fairness they never had the right incentives,’ says Ramanan Laxminarayan, who directs the US- and India-based Center for Disease Dynamics, Economics & Policy. He believes the industry can do more to ensure sales are properly regulated. ‘They have the muscle to do that, but haven’t exercised it.’

Another commitment is better access to drugs, especially in poorer countries. Industry is hoping that a Market Entry Award, as proposed by the O’Neill review, will help here. ‘You could either create a new global fund or let countries allocate a portion of a payment to reward a new antibiotic,’ explains Christine Ardal at the Global Health Policy Institute, who works on DRIVE – AB, a project looking at new economic incentives for antibiotic innovation.

Many in the field are adopting a wait-and-see stance on the roadmap. ‘I take all these commitments with some skepticism until they are acted upon,’ says Laxminarayan. ‘I hope the next press release will not be a promise but a report card.’ Anderson says more companies can sign the roadmap and hopes to give periodic updates on progress.

Drug firms facing challenging times due to price control


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 some of these challenges pragmatically to ease the operational environment for the pharma industry,” Hamied said.

The domestic pharma sector looks after the healthcare needs of India as well as many other countries, he added. “We are a major producer and supplier of affordable drugs worldwide. Many countries are dependent on India for their drugs. Now that our Indian pharma industry is at the forefront of healthcare, the government should be fully supportive,” Hamied said.

Calling for in-licensing system for patented and monopoly drugs developed abroad, Hamied said Cipla will continue its efforts to offer patients affordable essential medicines. “India needs a pragmatic in-licensing system for patented and monopoly drugs developed abroad. Your company, is more than willing to pay a reasonable royalty to the originator, to manufacture and/or market newer drugs in the country and also leverage our reach in the developing world to stay true to our mission of enhancing access and affordability,” he said.

Cipla is keeping all avenues open for appropriate licensing agreements with other global companies to make patients better secured for affordable treatment, he added. “Unfortunately for the nation in 2005, our government under intense international pressure changed the Patents Act, re-introduced product patents and backdated these to 1995. This change has already led to high prices of many vital drugs sold in India under monopoly,” Hamied said.


Life-saving drug disappears from market, CDSCO calls for meeting


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 Wilson’s disease,” said the letter written by Deputy Drugs Controller R Chandrashekhar to the five companies.

Panacea Biotec, Samarth Lifesciences, VHB Lifesciences and Chandra Bhagat Pharma Private Limited have been selling this medicine in India under the brand name Cilamin, Distamin, Artamin and Atrmin, respectively.

Therefore, a special meeting on the subject matter will be held by Dr G N Singh, Drug Controller General of India on September 30 (Friday)…to gauge the situation and examine the remedies to make the drug available in the country,” the letter added.

According to a September 16 petition on change.org by Wilson’s disease patient Piyush Gattani, the reason for this ‘real or artifical’ shortage is the government’s decision to bring this drug under price control.

This drug’s price has been fixed by drug price controller at Rs 138 per strip of 10 capsules. This molecule is not manufactured in India and it is imported, then capsulised and then sold by few pharmacy companies like VHB Lifesciences, Samarth Pharma, Chandra Bhagat Pharma. Due to non availability of raw material and higher cost due to duties, etc, it is no longer cost effective for them to import and sell this medicine. Probably this is the reason for the shortage,” Gattani said in his petition which requests government aid for patients suffering from the disease.

Government might have taken the decision in interest of the patients, however it has become counterproductive. DPCO should have kept the price which would have not caused the pharmaceutical companies to go in losses. This would have helped,” he added.

India to soon have separate pharmaceuticals ministry


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 of the year the country will have around 3,000 such centres that provide generic medicines to the poor patients at almost 40-50 per cent of the market price.

"Such centres will reduce the burden by 60 per cent. It is a great step towards improving the healthcare system," Kumar said.

PRADHAN MANTRI JAN AUSHADHI YOJANA
A countrywide campaign, for ensuring availability of generic medicines at affordable prices for all, under the project title Pradhan Mantri Jan Aushadhi Yojana (PMJAY) was initiated by the department of pharmaceuticals in association with central pharma public sector undertakings. It envisages key initiative of opening of dedicated outlets - Pradhan Mantri Jan Aushadhi Kendras (PMJAK) - where high-quality generic medicines are sold at low prices. Bureau of Pharma PSUs of India (BPPI) is implementing the scheme.

India has almost 10,000 pharma companies which are producing one lakh pharma formulation. The government has set up a pharma data bank in which the companies will have to register and give all the details. "About 63,000 formulations have been registered in the last two years. Pharma parks are being set up and many more will come up in the respective states of the country," he added.

CARDIAC STENT UNDER DRUG PRICE CONTROL DEPARTMENT
In an interesting move, the government has decided to bring cardiac stent under the drug price control department. According to the experts, the cost of the stent varies and it goes up to Rs 2.5 lakh. "We are going to regulate the price of cardiac stent to make them affordable for the common man. Patients are charged up to Rs 2.5 lakh," said Kumar. He cited a survey which showed that 90 per cent of the senior citizens at least take one medicine per day and almost 60 per cent of them take two to three medicines every day.

Talking about the importance of regulatory framework for affordable healthcare, he said that the "Modi's government policies are forwardlooking and caring".

"We want to be forwardlooking in terms of the quality. At the same time, we will be providing affordable medicines to the patients," he added.



Wednesday, 28 September 2016

Cipla Targets $1-b India Sales Through New Drugs, Tie-ups


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 said both Indian and multinational drug makers are approaching Cipla to partner for the India launch of several products.

And so, India will continue to launch 3% to 4% of our sales year-on-year and our volume growth will continue to be upward of 8% to 10%. We are looking at our India growth at 13% to 15% range, over a longer time period,” he said.

In 2014, Cipla partnered with Merck to sell its HIV drug brand, Isentress, under a different brand name.The same year, Cipla signed a licensing agreement with Gilead, alongside a bunch of other Indian companies, to market its Hepatitis C drug sofosbuvir.

An analyst said the plan to reach a billion dollar in India sales in the foreseeable future seems ambitious and may be “uphill“, unless the company signs deals of a substantial size, either for brands or companies or enter into strategic joint ventures with other drug makers.

Last year, Cipla changed its reporting structure for sales in the Indian market. It started booking revenues on actual sales against the earlier process, which booked sales at the stage of despatching the product.

Indian union plots mass protest against 'unfair' treatment of pharma sales reps


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 working conditions goes well beyond the Sun Pharma protest however, and comes after similar actions by other companies. On August 4, some 2,000 reps from Alembic Pharmaceuticals Ltd also went on strike to protest against "arbitrary" working conditions, forced transfers and anti-union action, says the FMRAI.

FMRAI supported the Sun reps' sit-out, after it filed a lawsuit in June seeking payment of unpaid monies and challenging demotion of sales staff, according to a Livemint report. Other Indian media reports suggest that around 24% of the combined Sun-Ranbaxy workforce has left the company since the takeover--and that the bulk of those departing are former Ranbaxy employees.

FMRAI alleges that unfair labor practices are rife in the Indian pharma market. Sales reps fear losing their jobs if they become ill--or simply at the whim of their managers.

Reps also risk "cruel and unjust punishment" if sales targets--which it says are often unrealistic--are missed. Managers dock wages or reject expense claims to retaliate, the union asserts, while the use of electronic reporting systems means reps can effectively be locked out of their work and dismissed "at the touch of a button."

The pressure put on reps hit the front pages in India after the July suicide of Ashish Awasthi, an Abbott Laboratories employee who left a note blaming his actions squarely on the pressure he faced over his sales targets.

The union wants India's government to set statutory working rules for sales employees and to strictly enforce the existing Sales Promotion Employees (SPE) Act. It's also calling for stiffer penalties--including the threat of jail--for employers found to have victimized staff.

"Field workers are determined to halt this outrage in the industries and refuse to allow the atrocities on the sales promotion employees to be passed up as such," it said in a statement.

Affordable drugs: India stand justified


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 third world and the developing countries in favour of affordable medicine.

While the rich nations had grudged the flexibility provided under the TRIPS, taking them as an affront against the pharma giants based in the US and Europe, the pains inflicted by the greedy drug makers are now being felt even by the citizens of the developed countries. The recent case in point is that of Mylan NV which raised the price of its emergency anti-allergy drug EpiPen, also taken by school kids, by 548% since 2007, selling a pack for $608. There is a public outrage against such a huge and unjustified increase in the price and the issue is being debated even in the US presidential elections.

Against this background, comes a report by the United Nations High Level Panel on Access to Medicines asking countries to use the policy space enunciated so well in the WTO’s TRIPS arrangement. Michael Kirby, retired judge of the High Court of Australia and one of the UN panel members, has made an observation which is so apt for countries like India, which have been at the receiving end of the campaigns launched by the powerful drug firms. In his observation, Kirby says the countries “which have been devout to take advantage of the TRIPS flexibilities guaranteed to them by TRIPS and Doha have suffered consequences from countries ascertaining their intellectual property.” India which has been supplying cheap and affordable medicines all over the world, through the generic versions, stands vindicated by the UN panel report which must be hailed in the larger interest, over and above sheer commercial considerations.

Fix India’s fragmented drug regulation


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 followed to be “vague” and mostly nontransparent. This cannot continue.

We need to overhaul the oversight regime, given India’s potential to be the pharmacy of the world. The Thakur report is categorical that there is no mechanism to ensure a nationwide withdrawal of a bad batch once it is established as being NSQ in a particular state. A more centralised regulatory system is possible by simply amending Rule 69 in the Drugs & Cosmetic Rules, 1945, the report avers. It also calls for a national NSQ database to vet credibility of manufacturers, and stresses the specific need for a public procurement law to regulate and mandate standards in the procurement of medicine. The bottom line is that proactive pharma regulatory reform would boost wellness, trade and the overall growth momentum.

Pharmexcil honours Ajanta Pharma Ltd


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.”


Drug pricing updates_The Bombay high court order allowing price caps


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 Paragraph 19 of the Drug Prices Control Order (DPCO)-2013 allowing the Government to regulate drug prices in “extraordinary circumstances, if necessary in public interest”. Until then, the NPPA could only cap the prices of “essential” medicines and scheduled drugs that figured in the National List of Essential Medicines (NLEM). With the IPA challenging the notification, Solicitor-General Ranjit Kumar told the Department of Pharmaceuticals that this power must be reserved for truly extraordinary circumstances such as epidemics, financial crisis, or a restricted supply of lifesaving drugs for a fixed time period. In September the government responded by directing the NPPA to withdraw the guidelines issued in May with prospective effect thereby allowing the July notification to stand.

Since the guidelines issued in May provided the rationale for the July notification it is quite strange that the latter was allowed to stand. Perhaps, the government was fearful that a climb down on the pricing would have hurt its public standing. But this is a loophole that the pharma companies will exploit when they take their appeal to the Supreme Court. However, the high court has noted that all pharma companies are not with the IPA in opposing the notification and some have accepted it. This is precisely the point of the NPPA order. The NPPA has restricted the prices only in cases where the MRP of the brand(s) exceeded the average price of all the brands in a drug category by 25%, and capped the new MRP at the 25% level. Moreover, the notification also allows the companies to hike the drug prices by 10% every year to allow for inflation.

These are reasonable regulations which will benefit a large number of patients without overtly curbing commercial interest. The demand for drugs is prescription-driven and patients have little choice in exploiting the inter-brand price difference in drug formulations because neither doctors, nor pharmacists, or the State educates consumers on alternate low-priced brands. The NPPA also points out that the differences in therapeutic value between high and low-priced brands of similar formulations are not significant. The NPPA has claimed that its actions in the past six months regulating the ceiling prices of 467 drugs has resulted in a direct benefit of Rs.2,300 crore to needy consumers. But the controls imposed by the NPPA on NLEM drugs covers just 18 per cent of India’s Rs1 lakh crore pharma sector. With the balance tipping towards lifestyle diseases away from communicable diseases it is important that the national list of essential medicines (NLEM), now having 875 drugs, is periodically reviewed so that the economic burden imposed by lifestyle diseases and lifelong medication is mitigated.

Tuesday, 27 September 2016

Pharma academic research - Indian patent applications published on 15th July 2016

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
3) Madhu Babu Ananthula
Lalitha College of Pharmacy, Ghatkesar (M),R.R.Dist Telangana.