Hyderabad - Biotech & Pharmaceutical Hub Updates

[sriece19]

USFDA lifts import alert on Aurobindo Pharma's Hyderabad facility

Aurobindo Pharma today said the US health regulator has lifted the import alert on its Hyderabad-based antibiotics facility, thereby allowing the company to export 9 products from this plant to the US market.

US Food and Drug Administration (USFDA) has lifted the import alert for non-sterile products manufactured at Unit-VI cephalosporin facility based in Hyderabad, thereby, paving the way for resumption of exports of 9 products to the US market, Aurobindo Pharma LtdBSE 11.67 % said in a statement.

"Prior to import alert, the unit was having annual US sales of USD 33 million for the said products," it added.

In 2011, the USFDA had issued an import alert on products from the company's Hyderabad-based cephalosporin facility, as a result of which its exports to the US market were affected.

The US health regulator had audited the cephalosporin facility, Unit VI of Aurobindo Pharma Ltd located at Chitkul Village, Hyderabad, Andhra Pradesh, in December 2010.

Subsequent to the audit findings, USFDA had imposed an import alert for detention on Aurobindo Pharma Unit VI products.

Cephalosporins are a class of antibiotics which are indicated for the treatment of infections caused by bacteria.

Shares of Aurobindo Pharma were trading at Rs 141.90 on the BSE in the afternoon trade, up 8.61 per cent from its previous close.

[Gudavalli]

Andhra Pradesh: From bulk drugs to affordable medicines, vaccines

In a span of three decades, Andhra Pradesh has seen the rise of more than a dozen big pharma and biotech firms. From being just a bulk drug manufacturing base, it is now a pharmaceutical and biotech hub.

“In Hyderabad, entrepreneurs are driven by a herd mentality. If there is one successful venture, a dozen will follow. The high number of bulk drug manufacturers in a way is just manifestation of such a trend”.

Habil Khorakiwala, Chairman of Wockhardt, made these remarks some time ago in the context of problems confronting the growth of the bulk drugs sector, faced with environmental issues, too many players, and problems in going up the value chain.

Hyderabad contributes to over 30 per cent of the country’s total bulk drug production. It was earlier 40 per cent. No wonder it is called the ‘Bulk Drug Capital’ of India.

Andhra Pradesh is home to 266 bulk drug manufacturing companies. Of these, 90 per cent are small and medium enterprises, around Hyderabad. Visakhapatnam is a recent destination, especially after the promotion of the Jawaharlal Nehru Ramky Pharma City. However, there is more than just the typical ‘follow a successful enterprise or entrepreneur’ streak among Andhra businessmen that has led to the impressive growth of the pharma sector in Hyderabad.

The public sector Indian Drugs and Pharmaceuticals Limited, the Regional Research Laboratory (now Indian Institute of Chemical Technology), with its focus on chemical sciences, and the various universities have all contributed to this special status for Hyderabad.

In three decades, Andhra Pradesh has seen the rise of pharma majors such as Dr Reddy’s Laboratories, Aurobindo Pharma, Hetero Drugs, Divi’s Laboratories, Matrix Labs (sold to Mylan Inc), Natco Pharma, Granules India Limited, Virchow Labs (the only manufacturer of sulfamethoxazole), Neuland Labs, SMS Pharma, Gland Pharma, Jupitor Biosciences, Lee Pharma, and Suven Lifesciences.

From just a bulk drug manufacturing base, the State has grown into a pharmaceutical and biotech hub.

NURTURING ENTREPRENEURS

While IDPL provided the environment for spawning drug firms in Hyderabad, the credit for turning the State into a breeding ground for entrepreneurs should go to Standard Organics Ltd.

It was one of the first private sector companies to venture into making active pharmaceutical ingredients (APIs) for multinationals. From here emerged Kallam Anji Reddy, founder and builder of global brand Dr Reddy’s Laboratories.

In a way, Standard Organics in the early 1980s and Dr Reddy’s in the early 1990s became the springboards for more than two dozen entrepreneurs, who built up companies of significant size.

They manufacture APIs and generic drugs, have US Food and Drug Administration approved facilities, and have a global presence in regulated markets as well as developing ones.

Dr Reddy’s, Aurobindo, Hetero and Natco Pharma, along with companies from Mumbai, Ahmedabad and New Delhi, have post the 1970 Patent Amendment Act (that facilitated process patents), brought generic drugs to the market, forcing global giants to cut prices while bringing medicines within the reach of the public in India and developing world.

In cancer remedies, the efforts of companies such as Natco Pharma challenging patent rights of multinationals and offering cheaper alternatives are proving beneficial to both Indian pharma and poor patients.

In at least two areas, Hyderabad has emerged a big supplier. First, in producing anti-retrovirals. Hetero Drugs, Mylan and Aurobindo are key contributors of such drugs to the Clinton Foundation as well as international markets and have helped alleviate the suffering of AIDS patients. For bird flu remedies too, Hetero has been a major supplier, procured a licence from Roche. According to Government estimates, AP has registered pharma exports worth close to Rs 25,000 crore and the industry is growing at about 20 per cent.

Another unique position held by Hyderabad in the national healthcare and pharma sector is as a major vaccine developer and manufacturer. Shantha Biotech (now owned by Sanofi Pasteur), Bharat Biotech International, Biological E and Indian Immunologicals are the leading players.

VACCINE HUB

Biological E, the first vaccine producer in the private sector in the South, is a major supplier of vaccines to the national immunisation programme.

It has developed a vaccine for Japanese Encephalitis. It has cut the prices for the pentavalent vaccine it supplies to the GAVI Alliance, which provides the vaccine to poor and developing countries.

The entire hepatitis B vaccine development was led by K.I. Varaprasad Reddy of Shantha and Krishna Ella of Bharat Biotech from Hyderabad in the mid-1990s. Then came the other over-half-a-dozen manufacturers, pushing down the price of this essential vaccine to around Rs 50 a shot in national programmes.

Advantage, tech & manpower

One of the key factors in the growth of the pharma, biotech and healthcare sectors in the State is the presence of research institutes and availability of skilled manpower. Two enabling facilities, in particular, have spurred growth — ICICI Knowledge Park and the Shapoorji Pallonji Biotech Park.

As Dr Reddy’s, Aurobindo, Natco Pharma, Suven LifeSciences and Zenotech Labs tried to move into drug discovery, and innovative research programmes, they were supported by the presence of research institutes and universities. The Indian Institute of Chemical Technology, a top research centre in chemistry and drugs, the Centre for Cellular and Molecular Biology (CCMB), the Centre for DNA Fingerprinting Technology (CDFT), University of Osmania, University of Hyderabad and Indian Institute of Life Sciences have all provided solid support in putting Hyderabad on the global pharma map.

In the recent past, research-driven companies such as AVRA Labs, set up by the former Director of IICT, A.V. Rama Rao, and engaged in contract research, are setting a new trend in the emergence of enterprises that have capability and expertise to do top-class work. Several contract research organisations (CROs) are now taking up outsourced opportunities from multinationals.

The US Pharmacopeia, one of the leading quality standards organisations for the pharma sector, has also set up facilities in the city, testifying, in a way, to the importance that Hyderabad has achieved in all aspects.

[thomasdesk]

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[sandeeprai99]

WASHINGTON: An eminent American university has signed an agreement to create a world class clinical pathology laboratory in the south Indian city of Hyderabad, as part of its effort to raise the health care standards in the country to the highest levels.

The University of Pittsburgh Medical Center, in a statement yesterday, said it is collaborating with the Citizens Hospital to establish a clinical pathology laboratory on the 10.5-acre campus in Hyderabad, to serve the population of more than seven million people in the metropolis.

Operating under the name AmPath, the lab initially is serving the Citizens Healthcare Campus, which has opened its first phase in August, including a dedicated oncology facility.

When fully operational in 2015, the hospital will include more than 650 patient rooms and offer the entire spectrum of health care services, the university said.

UPMC will help the lab expand its capabilities, including the addition of increasingly complex molecular diagnostic testing modalities. The facility is expected to become a reference lab serving patients throughout all of India, as well as the Middle East and Southeast Asia, the statement said.

"Advisory Services provides our clinical partners with access to a wide-ranging portfolio of UPMC's expertise, based on its position as one of the nation's most acclaimed and technologically sophisticated health care networks," said David Russell, who is leading the new group.

UPMC's international footprint already includes operations or services in Italy, Ireland, China, Singapore and Japan.

[Gudavalli]

Novartis India to organise BioCamp from July 8-10 in Hyderabad

Novartis India, a world leader in the research and development of products to protect and improve health and well-being, is organising three-day Novartis Biotechnology Leadership Camp (BioCamp) from July 8 to 10, 2013 in Hyderabad. BioCamp is a pioneering seminar which brings talented students from diverse faculties and different universities closer to the pharmaceutical industry.

Ranjit Shahani, vice chairman and managing director, Novartis India Limited said, “BioCamp is a great platform for intelligent, young minds to interact with leaders in the pharmaceutical industry. This three day seminar provides students the opportunity to look closer at the pharmaceutical industry and helps them make career choices. Healthcare is a challenging area in our country and BioCamp reflects the Novartis commitment to furthering the cause of healthcare.”

BioCamp is open to all postgraduate students and young researchers in natural sciences, medicine, biotechnology, bio-informatics, pharmacy, business administration or law (specialization in Intellectual Property Rights) interested in pursuing a career in the pharmaceutical/biotechnology industry.

Selected students will have the opportunity to learn from and network with leaders in the pharmaceutical and business sector as well as hone their team building skills. The top three students from the India BioCamp will represent India at the International BioCamp which will be held at Novartis global headquarters in Basel, Switzerland from August 25 to 29, 2013.

Since launching the BioCamp initiative in 2004, Novartis has introduced more than 500 top graduate students to the biotech industry and entrepreneurship. Besides regional events in various countries, global BioCamps have been held in Taiwan (2004), Singapore (2006), Tokyo (2007), Hong Kong (2008) and Cambridge, Massachusetts (2009) and since then in Basle, Switzerland.

[Gudavalli]

New vaccine could save thousands from deadly diarrhea-causing rotavirus

Scientists unveiled Tuesday an affordable vaccine against a deadly diarrhoea-causing virus that kills some 100,000 children in India every year.

Rotavirus, which causes dehydration and severe diarrhoea, is globally responsible for some 453,000 deaths annually and is particularly threatening in Africa and Asia, where access to urgent healthcare is often out of reach.

K. Vijaraghavan, secretary of India’s Department of Biotechnology which steered the hunt for an affordable rotavirus vaccine, said it was a product of international cooperation, although it has yet to be approved by New Delhi.

“The result is a world-class vaccine for India’s children,” he told a press conference in New Delhi.

“For the first time we have taken a vaccine from the earliest discovery to every stage of development and that is a very remarkable thing for India,” he said, adding that the dollar-a-dose oral vaccine was ready for production.

The vaccine named Rotavac will be manufactured by Hyderabad-based Bharat Biotech pharmaceutical firm which has said it has the capacity to mass produce 60 million doses after clearance is given. Each vaccination consists of three doses.

Rotavirus is blamed for causing up to 884,000 hospitalisations in India a year, at a cost to the country of 3.4 billion rupees ($72 million), scientists say.

“We have (now) added to our know-how and capacity in ways which will pay dividends for development of future solutions,” said Vijaraghavan.

Each dose of licenced vaccines from GlaxoSmithKline and Merc cost around 1,000 rupees ($18), said Sushmita Malaviya of PATH, an international healthcare organisation which is also part of the Rotavac programme.

M.K. Bhan, who pioneered the project after local scientists discovered a localised rotavirus 23 years ago in a New Delhi hospital, said the development was a boon for India’s creaky public health service.

“Total 25 percent of all diarrhoeal admissions would be prevented by this and that means you will have 25 percent less diarrhoeal illnesses of severe nature in India which is a very substantial public health gain,” he said.

“We have a good vaccine which will be useful and we will do post-marketing surveillance and keep accumulating more experience.”

More than 300,000 babies die within 24 hours of being born in India each year from infections and other preventable causes, according to a report last week by Save the Children.

[Gudavalli]

Dr Reddy's welcomes new pharma pricing policy

The Centre had ushered in a new regime for pricing drugs and issued a new Drugs (Prices Control) Order, 2013 which came into force on May 15

Hyderabad-based pharmaceutical major Dr Reddy's Laboratories Limited has welcomed the new pharmaceutical pricing policy announced by the Union government on Wednesday.

“We welcome this move as it ends the uncertainty on the pricing policy that has been stuck for so many years. The shift to a market-based price control model is commendable as it puts an end to the arbitrary pricing regime. The consumer stands to benefit with lowered prices of medicines,” Dr Reddy’s vice chairman and managing director, Satish Reddy, stated in a press release here on Friday

He, however, said there was a need for the government to balance the interests of improving affordability of medicines with growth for the Indian pharmaceutical industry, which was heavily dependent on investments into research and development. The latter needed mechanisms that would spur an increase in innovation spend in the country.

“At a company level, we were aware of the upcoming policy and have factored in the impact, which is likely to be in the range of 3-4% of our finished dosage sales in India. We have plans in place to ride over this impact,” Reddy said.

The Centre had ushered in a new regime for pricing drugs and issued a new Drugs (Prices Control) Order, 2013, replacing the DPCO of 1995. The National Pharmaceuticals Pricing Authority would implement the new policy and the new DPCO.

[sandeeprai99]

'World Pharma Trade Centre' in Hyderabad for which the state government has already earmarked 5 acres of land.

[Gudavalli]

India agrees to set up world pharma trade centre at Hyderabad

The Indian government has agreed to setup a world pharma trade centre at Hyderabad in Andhra Pradesh as the city has emerged as a hub for pharmaceutical industry in the recent times.

The decision was confirmed by the country's union minister of commerce Anand Sharma.

The proposed trade centre is likely to be located at Raidurg, an IT zone near Hyderabad, however, official details of the location and time-line of completion remain undisclosed.

About five acres of land has been allocated by the state government for the centre, which is likely to benefit several pharmaceutical firms and research institutions in and around Hyderabad in improving their businesses.

In addition, the centre will also help global pharma giants focused on drug discovery areas in establishing their facilities in the city.

[Gudavalli]

Goose launches new solution for pharma industry

Hyderabad, May 27 (IANS) Pharmaceutical business re-engineering solutions pioneer Goose Monday announced the launch of 'Goose quality manager' to help track and manage the deviations effectively.
The solution is designed to offer real-time corrective measures to tackle deviation across product manufacturing lifecycles that can disrupt good manufacturing norms and result in millions of dollars in revenue loss for the industry.
'Goose quality manager' provides real time visibility into various quality events and is loaded with critical modules to deal with non-conformances, internal and external audits, change management, Corrective Action and Preventive Action (CAPA), complaints and other modules for business functions, said a statement by the Hyderabad-based company.
Available both in basic as well as advanced version, what sets 'Goose Quality Manager' apart from currently available solution is its time to deploy and cost of deployment.
The significantly lower investment solution can be deployed in less than 3-4 months in organization of any size.
"Each manufacturing cycle is comprised of hundreds of steps and it is extremely difficult to manage deviations at each step when tens and hundreds of batches of different pharmaceutical formulations are running in parallel on any given day. Deviations that are not tracked and corrected can lead to adverse events like customer complaints, alerts and recalls which cause loss in revenue as well as brand value," said Deb Pattnaik, founder and CEO of Goose.

[Gudavalli]

Hyderabad firm makes reactors for pharma, fertiliser units

Its glass-lined vessels cost a third of those from foreign suppliers

HYDERABAD MAY 31:
A small, Rs 25-crore unit, tucked away in a remote corner of Jeedimetla industrial area in Hyderabad, will now be able to help bulk drug and fertiliser makers save crores of rupees by supplying a key input.

Started by a first-generation entrepreneur, the company, Standard Glass Lining Technology Ltd, is now the third firm in India to make glass-lined reactors, required by every maker of bulk drugs, fertilisers and chemical products.

GROWING DEMAND

The other two players — Indian subsidiaries of US-based GMM Pfaudler and France-based De Deitrich — can together supply hardly 60 per cent of the requirement of about 3,500 such reactors.

While the US firm’s subsidiary produces 800 units annually at its Gujarat unit, the other entity makes 1,200 units in Hyderabad.

The demand for this product is growing in India, as these sectors are switching over from plain stainless steel reactors to glass-lined ones.

The Hyderabad company has come out with glass-lined reactors using the latest patented technology of the Central Glass and Ceramic Research Institute, Kolkata which enhances the life of the reactors as compared with those in the market.

Its cost is just 30 per cent of the imported one, as it is indigenous.

“Pharma and fertiliser companies today have to wait for at least 25-30 weeks to get these reactors from overseas. We are now equipped to supply these in 4-5 weeks,” K. Nageswar Rao, Managing Director, said.

Rao was a senior official of De Deitrich, before he decided to start his own venture using CGCRI technology about a year ago.

Standard Glass has a capacity of 600 units a year, with reactors ranging in size from 63 litres to 1,600 litres, and priced between Rs 3 lakh and Rs 35 lakh.

“In the next two years, we plan to scale up capacity to produce 30,000-lt reactors, currently priced at about Rs 60 lakh each. Only Pfaudler makes such large reactors in India today,” Rao said.

CAPACITY

Even with this new capacity, there will be a shortfall of about 900 to 1000 units a year in the estimated Rs 300-crore market for such reactors.

“The demand is growing at 30 per cent. We have already received orders for Rs 1 crore from pharma majors, including Dr Reddy’s and Natco. We expect to get orders for 250-300 units in our first year of production,” he said.