Intellectual Thoughts by Sanjay Panda: 2013

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