Indian Chemical Industry to grow by 11-12%

The Indian chemicals industry, which earned revenues in the range of US$155-bn to US$160-bn in 2013, is likely to grow at a rate of 11-12% in the next two to three years. Though commodity and bulk chemicals are likely to experience slow growth, owing to reduced industrial output, the specialty chemicals segment should show faster growth.

Sectors such as personal care ingredients & additives,  active pharmaceutical ingredients (APIs), paints & coatings, and construction & water chemicals are some segments likely to perform well. "Even in 2013, these sectors showed good growth and companies in this segment have been investing and expanding.

The specialty chemicals sector is characterized by requirements for high-value products, expanding customer base, and addition of new participants at various levels of the value chain. Overall, the market is likely to grow at a Compound Annual Growth Rate (CAGR) of 13-14%. The sector forms about 15-16% of the total chemical industry, with dyes & pigments, leather chemicals, construction chemicals and personal care ingredients, being important constituents. In terms of production value, the specialty chemicals sector forms about 18-20% of the total chemical production in India. Though increasing regulatory requirements and raw material price fluctuations  have posed challenges for chemical manufacturers, exports have been increasing at a rate of 8-9%. 

CW

India commissions first major SBR plant

The commissioning of  Indian Synthetic Rubber Ltd. (ISRL, a JV of IOCL, TSRC, Marubeni) plant to manufacture  Styrene Butadiene  Rubber ( SBR)  is a significant milestone for  Indian  synthetic rubber industry. It will have the capacity to make up to 120-ktpa of the synthetic rubber. Till date India used to be  a 100% importer of SBR despite of huge demand of SBR.

SBR is the world’s oldest synthetic elastomer and also the most important, although demand for natural rubber is twice as much. The automotive sector is the largest end-use of SBR – accounting for 65-70% of global demand, mainly for tyre and tread. The first commercial processes for SBR produced emulsions (e-SBR), but later developments in solution polymerization have led to the development of s-SBR grades with superior mechanical properties, particularly tensile strength, low rolling resistance and handling, in tire applications.

Next  India will have its first butyl rubber plant. Polybutadiene rubber capacity is also being expanded.

USFDA increases inspections of drug facilities in India

USFDA  is increasing its inspections of facilities of drug makers in India, the second largest provider of finished dose products to the US, to ensure compliance of approved manufacturing norms. The US health regulator, which has been cracking the whip against many Indian pharmaceutical firms, including Ranbaxy, Wockhardt, is also recruiting and training additional drugs investigators in India. 

USFDA's presence in India is being increased to 19 from 12 American staff based in-country, including 10 dedicated specifically to medical products. Other staff include foods and devices inspectors, and policy analysts. 

In order to meet requirements of the new Food and Drug Administration Safety and Innovation Act (FDASIA) - Generic Drug User Fee Amendments (GDUFA), the US health regulator is stepping up the inspections. Under the FDASIA, the USFDA is required to achieve the same inspectional schedule for foreign facilities as domestic manufacturers, and to clear the backlog of applications by the end of the first five-year user fee authorisation period. 

India, as the second largest provider of finished dose products to the US with almost 10

per cent of that market.

Economies are faltering

A slowing down in growth rate, A record high current-account deficit. A weakening currency.  A spike in inflation.  A fall in the stock market, An increase in  job losses (right sizing or is it down sizing ) in  all most all the sectors. This is  a  phenomena happening in India”s  current economic scenario.  The economy is  worsening  day by day.

 

The same recipe that is creating India’s worst economic crisis in decades is now afflicting  few other  economies as well.   Indonesia  Consumer prices jumped 8.6 percent last month, the current-account deficit had hit  4.4 percent of Indonesian GDP.  Thailand  GDP contracted 0.3 percent in the second quarter compared with the first three months of the year. That’s the second quarterly contraction in a row for Thailand, which  confirms that Thailand is now   falling into recession.

 

A fierce selloff in many  economies ( Emerging /RDE) currencies shows no sign of abating as the expected withdrawal of US monetary stimulus prompts investors to shun markets seen as riskier because of funding deficits, slowing economies and  rising inflation. A decline in the Fed's bond purchases will push government debt yields higher, which should raise the attractiveness of the dollar and dollar-denominated assets. In many of these economies,  it has been hammered by doubts over the efficacy of policy actions to stem the rout.

In India, the rupee's sell-off threatens to drive Asia's third-largest economy towards a full-blown crisis. While the Indian government and central bank have unveiled measures ( though not enough) to support the rupee, investors are unimpressed. Bolder structural reforms, including greater fuel price liberalization, land acquisition reforms, and higher foreign investment limits in  retail, insurance,  and  few other industry are crucial to regain investor confidence and shore up the rupee else we are slowly approaching the early 1990’s.

 

The new Drug Pricing. Battle Escalates !

Several pharma  companies  & Industry bodies like Indian Drug Manufacturers Association, Confederation of Indian Pharmaceutical Industry (CIPI)  already moved  to Court  and  few more expected join, to challenge the government's new drug pricing order that asked them to slash prices of 348 medicines and also  replace stocks in the market with those carrying reduced prices within 45 days of new price notification. 

The DCPO had ordered  earlier for reduction of prices of some medicines within 45 days of issuance of the  notification and that the decreased prices be made effective on drugs already in market.The deadline for  implementation of the notification ended on July 29.

Earlier  Indian Pharmaceutical Alliance,  estimated that with the application of the new price fixation methodology on a completely new set of medicines may see the Rs 100,000-crore industry losing about Rs 2,500 crore in revenues in the near term. Market intelligence firm AIOCD-AWACS estimates that the new price control system may hit the domestic revenues of majors Ranbaxy and Cipla by 6.2 and 5.8 per cent, respectively. 

 
Prices of 348 medicines, including life saving drugs are set to be cheaper by up to 80 per cent as the new Drug Price Control Order has come into effect.

As India pushes for compulsory drug licences,others looking for the new twists

The fight over drug patents in India is quickly spreading to  other areas  as other countries are looking at new twists on the model for getting their hands on cheaper drugs.

BDR Pharmaceuticals  has asked the Indian patent office to give it a compulsory license for a generic version of  BMS’s  cancer drug Sprycel (Dasatinib). Earlier Indian Supreme Court upheld the country’s first compulsory license granted last year to Natco Pharma to make a generic version of Bayer's kidney cancer drug Nexvar. It justified the decision to override the patent on prices. Natco began selling Nexavar for $170 a month, compared with Bayer's $5,000/month.

Others companies have also seen patents breached in recent months. Pfizer suffered the loss of IP protections on its cancer drug Sutent ( Challengers : Cipla & Natco ) and Roche's patent coverage on the hepatitis C treatment Pegasys been revoked.(Challengers : Sankalp Rehabilitation Trust)  Novartis  is still fighting for patent protection on its blood cancer treatment Gleevec (Challengers : Several Indian drug companies, Government of India)   and the Indian government has moved toward compulsory licenses on Roche's Herceptin.

Proponents of the aggressive attacks on patents say it is the only way for poor people in emerging countries to have a chance of getting the same lifesaving treatments that others in the world enjoy. It is an argument that has traveled well. 

China granted itself compulsory licensing rights last year but has yet to exercise them. Now a lobbying group is pushing Greece to adopt a compulsory license law, but not so Greek companies could make generics. The idea is that once the patents are neutralized, Greece could import cheap generics from other countries, like India.

Under India’s patent rules, compulsory licences can be issued when an inventor company fails to supply products at an affordable price. In such instances, other companies can go to court to get a licence to make the same products.

Reacting to  the such developments some U.S. Congress members said if India is going to continue to play loose with patent protections, maybe the U.S. needs to rethink an exemption for India on import duties that comes up for renewal in July.

Mylan to buy injectable drugs unit of Strides for $1.6 billion

Strides Arcolab Limited today announced that it has entered into a definitive agreement for the sale of its specialties subsidiary, Agila Specialties Private Limited, to US-based Mylan Inc  thus  ending  months of speculation regarding its sale, with reports suggesting Pfizer and Japan's Otsuka Holdings as other potential buyers.

Under the terms of the agreement, Strides and its subsidiary will receive an aggregate sum of $1.6 billion in cash on closing and a potential additional milestone payment of $ 250 M subject to the satisfaction of certain conditions by Strides.


This  deal will help Mylan, one of the world's largest generic drugmakers, to double its injectable drugs portfolio in combined  to more than 700 marketed injectables products and a global pipeline of more than 350 injectables products pending approval.

Media reports

Indian Regulator sets deadline for drug launches

Pharmaceutical companies will have to launch drugs within six months of getting approval from the drug regulator, failing which they could lose the manufacturing license.   According to the Indian Drugs and Cosmetics Act, for any new drug, pharmaceutical firms should file a periodic safety update report (PSUR) every six months, for the first two years and  once in a year for the subsequent two years.  This enables authorities to monitor the safety and efficacy of a new drug in a post-marketing scenario for four years, after which it no longer remains a new drug.

“It has been decided in public interest that in case an applicant/manufacturer fails to launch the product for marketing in the country within a period of six months from obtaining the permission or license, the permission/licence will be treated as cancelled,” said the DCGI

AstraZeneca's Cancer drug Patent Plea Rejected in India

In a setback to AstraZeneca, the Intellectual Property Appellate Board (IPAB) has dismissed its appeal against an earlier ruling that refused it a patent on lung cancer drug Gefitinib. The Indian patents office in 2007 refused patent protection to AstraZeneca, citing lack of invention. The Intellectual Property Appellate Board (IPAB) now upheld the refusal.

In its appeal, Astra Zeneca earlier had argued the controller had erred on various aspects of patent determination and also in concluding that the comparison test did not establish increased efficacy of the drug.

Innovators  suffered a reversal in March when India granted the first ever compulsory licence to Natco Pharma to sell Bayer's cancer drug Nexavar  equiavalent. Bayer has appealed  against the order.

And early this month IPAB revoked a six-year-old Indian patent granted to Roche's hepatitis C drug Pegasys, citing lack of evidence that the drug was any better than existing treatments.

Source:  newspaper & media reports

Generic drug manufactures to pay more for registration in US

US FDA recently made amendments to introduce a generic drug user fee. According to the new law, The Generic Drugs User Fee Amendment (GDUFA) of 2012 — companies will have to pay a fee ranging between $17,435 and $51,520 an application to seek an approval. Besides, drug makers will also have to pay for inspection of their facilities by the FDA outside the US, and for supplying active pharmaceutical ingredients (APIs) for manufacturing generic drugs in the US.

According to US FDA, companies will have to pay $17,434 per generic drug application pending without tentative approval till October 1. For applications seeking generic drug approval on or after October 1, companies will have to pay $51,520, whereas for Drug Master File companies are required to pay $21,340.

OTC sale of around 92 antibiotic and anti-TB drugs will be clamped down in India soon

Resistance to antibiotics is becoming a serious threat to Indians because of popular habit to pop pills at will which is an irrational use.  A recent study by the Centre for Disease Dynamics, Economics and Policy, said there has been a six-fold increase in the number of antibiotics being popped by Indians.

In order to avoid such irrational use, DCGI has written to the Union health minister to notify a new schedule H1 in the Drugs and Cosmetics Rules. Once notified and following the clearance from the law ministry, these drugs cannot be sold without prescription. These drugs will also have to carry a prominent label in red colour with the following warning: "It is dangerous to take this prescription except in accordance with medical advice and not to be sold by retail without the prescription of the registered medical practitioner."

This is a very welcome news as we and world, staring at a post-antibiotic era, when common infections will no longer have a cure.

Source : Media reports

Pollution-related issues are haunting few AP Pharma units

While the Visakhapatnam district administration has sought the closure of the Mylan unit along with four other units in the pharma city operated by Ramky, the Andhra Pradesh Pollution Control Board (APPCB) has issued closure notices to 12 units around Hyderabad.


It is believed that villagers near Ramky’s Vizag pharma city have been complaining that the units there pollute air, affecting their health. In response, the district administration swung into action to verify the veracity of their allegations. According to sources, the APPCB, acting on the district administration’s request, conducted a study and confirmed air pollution. This led to immediate closure notices for five units (belonging to Mylan, Vegesna Laboratories, Actus Pharma, Vijay Organics and Acacia Life Sciences, respectively).

The Andhra Pradesh Pollution Control Board (APPCB) has issued closure notices to 12 bulk drug units located in Hyderabad while directing their managements to stop all the industrial activities by July 23, 2012. Of the 12 bulk drug manufacturing units currently under the PCB axe, two units belong to Aurobindo Pharma while four units are of Hetero Drugs Limited.

The units involving other companies are Crix Pharmaceuticals, Covalent Laboratories, Divis Pharmaceuticals, Krishna Pharmaceuticals, Innogent Laboratories and SMS Pharma Limited.

In a press release, the board said that these units were asked to close down under the Water & Air Acts in the interest of protecting public health and environment. “After detailed discussions, the board is of the firm opinion that certain industries are violating the orders of the Supreme Court of India and the ban notification issued by the Andhra Pradesh government, among others,” the press release said.

 
( source:   news  papers and  press releases)

Another Block buster bites the dust

Yet another milestone on pharma's journey away from the mega blockbuster era: Plavix (the world's second-best-selling medicine) goes off patent. And unlike Pfizer BMS plans to back off Plavix marketing immediately. Thanks to the monopoly Plavix enjoyed, USD 9 Billion on its peak and it brought in $6.6 billion in net U.S. sales last year and the drug has generated an estimated $42.8 billion for the company during its 15 years on the market.

FDA said it gave seven companies permission to sell generic Plavix or clopidogrel in the standard 75-milligram dose. According to the FDA, 75-milligram generic Plavix can now be sold by Apotex Corp., Aurobindo Pharma, Mylan Pharmaceuticals, Roxanne Laboratories, Sun Pharma, Teva Pharmaceuticals and Torrent Pharmaceuticals.

The larger dose of 300 mg will be sold by Dr. Reddy's Laboratories, Gate Pharmaceuticals, Mylan and Teva.

India To Probe Alleged Irregularities Within Drug Regulator

The government of India announced an inquiry on the functioning of the main drug regulator, after a parliamentary report exposed dysfunction within the agency and serious irregularities in the drug approval process.

The government said in a statement that it had appointed three experts to look at the scientific basis of approving new drugs without clinical trials and recommend ways of improving the procedures of the Central Drugs Standard Control Organisation (CDSCO).The parliamentary panel accused some officials of the CDSCO of colluding with multinational and Indian drug firms to bypass normal approval procedures.

(Reuters)

Indian Rupee sliding.....

Rupee is under serious pressure.  Dropped from Rs 44 for a dollar in August 2011 to almost 55 in early May 2012 especially the rate of fall , after a pulling back above the Rs 49 mark during Jan-March 2012. The slide perhaps contributed to S& P decision to downgrade India’s outlook and current balance of payment situation. The Current account deficit likely to hit more than 4% of GDP and a worsening trade gap complicating the situation further. The trade gap likely to widen further as one of the biggest forex earner, the IT industry seems to be loosing its shine.

With a high external debt repayment in next several months and possible portfolio outflow, seems we are moving to a crisis situation as far as value of INR is concerned.

Roche to sell cheaper cancer drugs in India

Just days after officials in India stripped Bayer of its exclusive rights to Nexavar, giving a local company NATCO the right to produce it at a deep discount,

Roche has stepped up with plans to slash the cost of two of its blockbuster cancer drugs.  Herceptin and MabThera will be offered in cheaper new versions from an Indian partner.

original report

Indian Patent office invokes compulsory licensing rule, Natco to sell generic version of Nexvar

Bayer has lost a landmark drug ruling in India, forcing it to grant a compulsory licence for its cancer treatment Nexavar to Natco Pharma in a move that could bring down the cost of other pricey medicines.

The Indian Patent Office issued its first ever compulsory licence to Natco, a local generic drug manufacturer, effectively ending the German drugmaker's monopoly in India on the drug for treating kidney and liver cancer. Natco has been allowed to sell the drug at a price not exceeding Rs 8,880 for a pack of 120 tablets required for a month's treatment as compared to a whopping Rs 2.80 lakh per month charged by Bayer for its patented Nexavar drug.

As per WTO agreement, a compulsory license can be invoked by a national government allowing someone else to produce a patented product or process without the consent of the patent owner. It is done for the cause of public health. The move, however, will unnerve international pharmaceutical companies. They are eyeing emerging markets like India as a major growth opportunity but remain worried about intellectual property protection in such countries.

BW,BS

Wyeth Claims $960M from Sun Pharma In Protonix Case

Wyeth Pharmaceuticals Inc is seeking $960 million in damages from Sun Pharmaceutical Industries for alleged patent infringement in launching a generic version of Protonix ( Pantoprazole) in the United States., The original patent relating to Protonix, is held by Nycomed and was licensed to Wyeth, which is now owned by Pfizer. Sun launched its generic version of Protonix tablets in January 2008 after Teva Pharmaceutical Industries and its US subsidiary began selling the drug in December 2007.

Watson buys Stride's Australia Business

Watson Pharmaceuticals expanded its reach in the Asia-Pacific with a deal to buy Strides Arcolab's Australia-based generics business,( Ascent Pharmahealth) . The buyout not only gives Watson a major presence in Australia, where it becomes the fifth-largest  generic drugmaker, but it also  a  No. 1  position in Singapore.

Statin use linked to more diabetes in women: US study

Cholesterol-lowering drugs known as statins may be linked to an increased risk of diabetes in middle-aged and older women, according to a US study. A six- to seven-year study shown nearly 50 per cent more likely to be diagnosed with diabetes than those not taking statins.

Previous studies, mostly in men, have suggested a smaller 10 to 12 per cent increase in diabetes among statin users.

The conclusion still stands that overall, those people who've got existing heart disease or have had previous strokes, they still would get vast benefit from statins.

India: emerging in Specialty Chemicals

India has slowly becoming a significant player in the international chemicals market. As India's edge in speciality chemicals is more and more visible, it is not just multinationals that are ramping up their sourcing plans from India; even home-grown firms are creating new capacity, increasing productivity and going in for acquisitions. MNC’s like BASF, Clariant, Lanxess, Chemtura etc are already invested significant amount and in the process of investing additional capital to expand their business.

India is expected to drive growth in the $650 billion global speciality chemicals market. India's speciality chemicals industry is expected to grow at a CAGR of 15% - almost double the growth of the global industry. Exports of speciality chemicals from India are poised to grow from $4 billion in 2007 to $13 billion in 2013, representing a CAGR of 22%.

The largest exporter of chemicals in the world is still Europe with $955 billion The EU still accounts for 90% of total chemical exports. They are the world leaders not just in production, but also the largest exporters. The second largest is the USA with $180 billion. India exported just $24 billion which is quite insignificant at this moment.

India has improved from its export figure of $22 billion two years ago, but China had clocked chemical exports worth $88 billion. Japan had $78 billion worth of exports. Though India's growth is good as compared to the past, even fantastic, it is rather small if one compares to China.

FDI in Indian retail

Decision to allow 51 per cent FDI in multi-brand retail and 100 per cent in single-brand retail should easily count as one of the boldest economic reform measures initiated by the government. At this moment all the poltical parties are opposing the idea in the pretext of that this move would destroy domestic small retail businesses and result in more job losses. They think fears of wiping out small retail shops and kirana ( mom and pop)stores.  But comfort should come from the many conditions that have been attached to the entry of foreign capital into the sector. Retail multinational, keen on entering India with a 51 per cent equity, will be required to procure at least a third of their raw materials from small Indian companies, allocate a minimum of 50 per cent of their investments to create backend infrastructure and operate only in towns or cities with population of more than one million. These are tough conditions and should be able to address fears of job losses with the advent of big retail multinationals.

On the positive side, the entry of big retail should result in a marked improvement in the efficiency of the retail chain. Large multinational retail firms will bring not only their capital but also more advanced technologies and processes that will bring down transaction costs and improve the retail delivery system. It is also expected that the presence of big retail chains and competition will have an impact on inflation. 

The share of organised retail in the total retail business in the country, estimated at around Rs 25 lakh crore, is still very low, at only seven per cent. China’s share of only the top 100 retail groups in its total retail business is over 11 per cent. Clearly, India has much to catch up on, and the decision to allow FDI in the retail sector should help start the process.

BS

Roche R&D chief affirms $10B peak potential for HDL drug

Who says the mega-blockbuster is dead? Certainly not , as per, Roche research chief Jean-Jacques Garaud, who believes that despite the troubled history of CETP inhibitors.Roche’s HDL drug “dalcetrapib” has the potential to earn upwards of $10 billion a year. And Garaud shrugged off the prospects of Merck's rival HDL drug "anacetrapib", which has done even better in the clinic at boosting levels of "good" cholesterol.

Even though their (anacetrapib's) HDL elevation is higher, that might not be the best marker for potential activity,. "What is important is how much cholesterol we pull from the blood. We think ours is better than any other drug , he said.

But even more importantly than the positive data on HDL levels, Roche's investigators recently were able to reassure observers that in mid-stage studies the drug appeared safe, with no spike in blood pressure.

Merck, of course, may not be ready to take a back seat to dalcetrapib. In a Phase II trial their drug was linked to a whopping 138% rise in good cholesterol and a 40% drop in LDL levels.  That's a much better result than the 31% boost in HDL levels seen in a mid-stage study for dalcetrapib. Vontobel  estimated potential sales of $5 billion a year whereas. UBS projected peak sales at $6.8 billion.

Reuters

Ranbaxy may sale Generic rights of Lipitor if the approval gets delayed

Ranbaxy may sell rights to make a generic version of Pfizer’s Lipitor, the world’s best-selling medicine, should it fail to win timely U.S. approval for the cholesterol pill, said Credit Suisse. 

A legal settlement with Pfizer gave Ranbaxy six months’ exclusivity to market generic Lipitor in the U.S.    Delays in USFDA  approval may prevent Ranbaxy from selling its copies as planned from Nov. 2011.   Lipitor is the highest-selling drug of all time, generating $10.7 billion last year. The most likely outcome will involve Ranbaxy paying a hefty fine to the FDA, which would subsequently clear the path for Lipitor approval.The company and most industry experts remain confident a resolution will be reached in time for Ranbaxy to launch on Nov. 30. 
If the Nov. 30 deadline isn’t met, Ranbaxy may postpone the release of its copycat Lipitor, said  the Credit Suisse report .  This would also delay the timeline for other generic manufacturers wanting to sell their own copies, as Ranbaxy’s 180-day exclusivity period does not start until it begins commercial marketing.   This  delay may  benefit Watson Pharmaceuticals which negotiated with Pfizer to begin selling a so-called authorized generic by Nov. 30. Alternatively, Ranbaxy may waive exclusivity in exchange for payment from a rival generic-drug maker, Credit Suisse said.