Pfizer plans to close its 50-year old Thane facility in September

Pfizer, a Rs. 1,800 crore plus pharma MNC after merging Wyeth, has decided to shut down its over 50 years Thane facility from September 16, 2015. The decision to close the site is based on an assessment its long term viability and its ability to achieve the needed production. There has practically been no production activity at this plant since 2013, and the closure will not impact the supply of any of our medicines to patients.

The company had offered a generous voluntary retirement scheme (VRS) to the workmen at this site last year, upon their request. This was taken up by as many as 132 of the 212 workmen. The remaining 80 workmen have continued to receive full wages, despite plant inactivity. As a part of the closure process, the company will honour its obligations towards requisite compensation, as mandated by law, for the remaining workmen. We are grateful for the contribution of the workmen and colleagues and will ensure that they are treated with fairness and respect.

Pfizer remains committed to providing high quality medicines to our patients and customers in India.

Government to soon come up with 10 pharma clusters in the country

While releasing the report of proceedings at the 12th National Pharmaceuticals Conclave recently, Union chemicals and fertilizers minister Ananth Kumar announced setting up of 10 pharma clusters in the country with an outlay of Rs. 120 crore in the next one year. He explained that these clusters will provide common facilities to the pharmaceutical industry, and help them hive off up to 25% of the cost, making them globally competitive. A strategy to develop the clusters has been framed for its early implementation, he informed.

The Minister further said that that there are valuable suggestions in the report which will be promptly examined, and taken up for action. He said that the Government wants to ensure that four pillars of the industry - Quality, Affordability, Availability and Stability are in position. He said that the Government wants to provide health security for the poor people of the country, and this requires innovative strategies, like supply of generic medicines, building domestic capacity in bulk drugs, and making pharma sector competitive.

A unified policy, regulation and administration mechanism is required for the pharmaceutical industry, and the Minister has therefore recommended to the Prime Minister to set up a separate department for the same. He said that on the issue of bulk drugs production in the country, Katoch Committee Report has been received in the Ministry, and an action plan is being prepared for its implementation. Once its recommendations are put in place, it will make Indian industry viable and competitive.

Speaking on the occasion, the Minister of state for chemicals and fertilizers, Hansraj Gangaram Ahir said that close interaction with producers and consumers helps the Government in formulating a better policy. He said that industry and national growth go hand in hand.

Lupin buys balance 40% stake in South African-based Pharma Dynamics

Lupin, the fourth largest pharma major with net sales of Rs. 11,200 crore plus, has entered into an agreement to acquire the balance 40 per cent equity stak e in South African generics major, Pharma Dynamics (PD)  from its founders.

As per the agreement, the found ers will exercise their put option before March 31, 2015, for  the 40 per cent equity stake it currently holds. On comple tion of this transaction, PD will become a wholly owned  subsidiary of Lupin, subject to closing conditions.

Headquartered in Cape Town, South Africa (SA) Pharm a Dynamics was founded in the year 2001 and distributes a range of branded, generic prescription medicines and over-the-counter (OTC) products in SA as well as other key markets across the African continent.

It was in September, 2008 that Pharma Dynamics (PD) and Lupin Limited set out on a shared mission to provide effective and affordable healthcare products to patients in South Africa and the African continent. Lupin acquired a strategic 60 per cent equity stake in PD. Today, PD is amongst the fastest growing top 20 pharmaceutical companies in SA and the 3rd largest generic company in the SA prescriptions market. It is the biggest supplier of cardiovascular pharmaceuticals in SA by both value and volumes. Its products also address therapies such as central nervous system (CNS), gastrointestinal, diabetes and gynecological and male health segments. In 2013, it also entered the SA anti-infective market, supplying IV antibiotics to hospitals. Its OTC products portfolio includes antihistamines, cold & flu medication and heartburn treatment.

Talking about the development, Paul Anley, CEO of Pharma Dynamics said, “Lupin has been an extremely strong partner in our business since 2008 and we have always had an excellent relationship” he further added, and “The fact that Lupin has increased its shareholding in Pharma Dynamics is a huge compliment and augers very well for our continued success.”

The acquisition represents significant foreign investment into SA and is a major vote of confidence in the business. It will add additional global muscle to Pharma Dynamics’ operations and support the next phase of growth for the company.

Karnataka pharma heading for major crisis

Karnataka pharma companies are apprehensive about the growing power crisis in the state as the industry is forced to put up with poor electricity supply. This follows after the minister for energy DK Shivakumar indicating in during the State Assembly sessions on the government’s inability to provide 24/7 power supply owing to daily shortage of 1,000 MW of power.

The state government has now expressed that it would not be able to supply the required power to both the industry and households. This has led the industry to revise its production plans.

 
The pharma companies are already forced to put up with the hike in power tariff hike of 66 paise as proposed by the Karnataka Electricity Regulatory Commission (KERC). Now the industry is facing the continuous power crisis and the drug manufacturers are forced to re-align their production schedules which are hampering the operational loads, Jatish N Sheth, president, Karnataka Drugs and Pharmaceutical Association told Pharmabiz.

Need of the hour

The 2012 Patient View survey of 600 international, national and regional patient groups, on the corporate reputation of pharma in general and 29 leading pharma companies in particular showed that the overall industry reputation has dropped. In terms of reputation, the pharma industry was 7th of the 8 healthcare sectors evaluated. Only 34% of respondents gave pharma a “good” or “excellent” rating for reputation. Pharma trailed retail pharmacists (62%), medical device companies (50%), private healthcare services (46%), biotech companies (44%) and generic drug makers (37%).

From a patient’s perspective this negative view of pharma is being driven by:
1)    A lack of fair pricing policies leading to unseemly profits (50%);
2)    A lack of transparency in all corporate activities (48%);
3)    Management of adverse event news (37%);
4)    Acting with integrity (32%)

Till the final quarter of the last century, the pharmaceutical industry's social, political, technological and economic credentials were unparalleled. Its range of noble and altruistic ideals attracted the best and brightest graduates who delivered an outstanding range of new medicines. Its single-minded pursuit of integrity was widely respected and its reputation, image and influence were without equal.

Pharmaceutical policy for Telangana

The pharmaceutical association of Telangana (TPA) has demanded the state government of Telangana to come up with a comprehensive pharma and biotechnology policy to attract more investors and enhance growth in this sector.





At present there are 412 pharma companies and 173 bulk drug units in Telangana state. Earlier the total count was about 1500 pharma firms in the united Andhra Pradesh. In the year 2005 about 300 firms had shifted to tax incentive states like Uttarkhand, Gujarat and Himachal Pradesh. Now that the State of Andhra Pradesh is divided into two, the Telangana Pharmaceutical Association fear that the remaining firms may also shift their bases to Andhra state, as the AP government has been luring with numerous incentives and benefit packages for the investors.

In view of this, the TPA has demanded the Telangana Medical, Health and Family welfare Minister Dr.T.Rajaiah to come out with a comprehensive pharma policy and announce incentives and tax exemptions. The association has also demanded to increase more number of public private partnership programme to attract new investor and at the same time retain the existing companies in the state.

Untested - Drug's

Central Drugs Standard Control Organisation last week came out with a stand that it will not review or recall the 33 controversial drugs found to have been approved for marketing in the country during 2008-10 without clinical trials by the Parliamentary Standing Committee on health & family welfare. The conclusion of the Parliamentary Standing Committee was that  a collusive nexus existed between medical experts, pharmaceutical companies and the CDSCO officials while approving drugs for marketing in the country.

The report of the panel also pointed out the unethical deals between the pharmaceutical companies and the regulatory officials in getting approved the unsafe drugs in India. The CDSCO is of the view now that approvals granted by the competent authority were 'in order' and there was no need to re-examine the approvals or recall any  drug from the market on grounds of errors in approval process. Therefore, there will be no action with regard to these 33 drugs unless some specific instruction come from the Union Health Ministry.
 
An expert committee has been constituted to suggest measures to improve the functioning of the office of CDSCO and DCGI soon after Standing Committee’s report came out last month. The three-member committee is headed by V M Katoch, director general of the Indian Council of Medical Research. This committee is also expected to look into specific cases against medical experts and suggest actions to be taken by the Medical Council of India.

The health ministry has  to remember that there was tremendous  pressure from the public interest groups and independent medical experts for taking immediate action to suspend marketing of these drugs circulating  in the country. The fact is that these drugs, without assessing their safety and efficacy, are already there in the market and are being prescribed by the physicians. It is quite difficult to estimate how many people might have already injured and suffering due to intake of such untested drugs. No drug control administration should ever dare to allow the pharma companies to market any medicine without proven efficacy and safety. 

R&D market -Challenges

The Research and Development market has seen the greatest changes over the last 10 years within the industry. With big pharma wrestling to adapt a formerly successful model that each year is producing decreased levels of output, we are now amidst the middle of the cycle with a move away from investing in single large-scale R&D sites to diversifying interests across geographic regions, technologies and partnering firms.

This approach is leading itself to increased open innovation, out-licencing and in-licencing of technology, and outsourcing models that drive down development costs and even partnering and profit sharing arrangements.

The downsize of this approach has obviously been that it has decentralised regulation and increased the number of different methodologies used- meaning that many projects have a unique set of challenges and a greater degree of variants between timelines.

This model, however, has matured over the past couple of years and we are now seeing a solution that enables increased innovative output from the R&D industry, whilst maintaining a more standardized approach to R&D and, crucially, approaches to measure effectiveness and ROI.

This CPhI Pharma Insights Report examines the current trends in evaluation, adoption and partnering solutions that have been implemented across the industry to drive greater innovations and cost efficiencies.

PHARMA - Mastered the art of serving the lower part of the income pyramid profitably

            ·         Mass-market techniques to deliver complex services

So focusing on the masses isn’t proving any easier than focusing on the affluent elite who can pay for costly new medicines. But that doesn’t mean it’s impossible to make a profit in the growth markets. On the contrary, there’s much pharma can learn from the most innovative organisations.

·         Designing products for people in the lower part of the income pyramid 

           

When Ratan Tata decided to develop a car for India’s urban masses,

 he started with a question: how to produce an affordable – and better – mode of transport for people who normally used motorbikes. The result was the $2,500 Nano, a fuel-efficient vehicle that seats four passengers but comes without expensive frills.

·         Mass-market techniques to deliver complex services

Dr Devi Shetty has perfected the science of high-volume heart surgery. At Narayana Hrudayalaya Hospital, in Bangalore, India,  42 surgeons – each specialising in a single procedure perform some 600 operations a week. Dr Shetty charges about $1,500 per operation. Yet his profit margins are higher than those of the typical US hospital, and his quality as good.

Eye-hospital chain Aravind has also used assembly-line techniques to deliver healthcare. It performs about 350,000 operations a year and its operating rooms have at least two beds, so that surgeons can swivel from one patient to the next.

·         Pooling resources for different purposes

When Simon Berry, founder of British charity Colalife, wanted to distribute anti-diarrhoea products in the developing world, he had a brainwave: Coke gets everywhere aid doesn’t, so why not pack the crates with medicines? Colalife designed a wedge-shaped container that fits between rows of Coke bottles and is now piggybacking on Coca-Cola’s distribution network.

Anticipate that, by 2020, the biggest pharma companies will be pooling resources with health insurers and community care providers in the growth markets to stimulate demand for their products. They’ll also be participating in cross-industry transportation networks to reduce their distribution costs.