Investment Scenario in Indian Lifescience Industry!

Kriti Jaiswal l 03/01/2014

In spite of the falling rupee, rising inflation and tightening policy controlmeasuresimplanted by the RBI, the Indian market is still attractive to the foreign investors according to a report published by Ernst and Young. The report claims that the Indian markets are better suited for investments, than US and China.

The most lucrative sectors were automotive, technology and life sciences and consumer products. An industry expert was quoted saying that the investor outlook for India remains positive, despite challenges the country’s slowing economy has faced.

But many view the FDI with its good and bad side effects.   The industry experts believe that FDI should be allowed but with regulations. Some even stress and say that “a drugs price is not decided by the multinational company but by the country’s policy.”  Others site China’s example and press upon the need for FDI in the country.

The bad effects of having foreign direct investment in the pharma sector would mean a reduction in the supply of cancer vaccine and other active pharmaceutical ingredients. Also popular generic drugs which are cheaply produced by Indian pharma companies.  These would be the result of foreign companies completely taking over the Indian companies. Foreign Investment anyways would imply looking for greater profits which would mean an increase in drug prices.

Indian companies always function with the objective of welfare motive and also follow the policies and adhere to the regulations laid down by the government. This often enables the production of many cheap drugs which are not only consumed in the Indian markets but also in other developing countries. Hence a large part of the drugs and vaccine produced by the Indian pharma sector is exported, which infers that the Indian pharma sector is not running into losses and is making profit, as there is a great demand for cheaply produced drugs and vaccines.

 The responses are mixed. The FDI question has the negative and positive side.  What the country embraces is yet to be seen and it will unfold in the next few months to come.

 Sources:

http://www.firstpost.com/business/cabinet-may-decide-to-reduce-fdi-in-pharma-to-49-percent-1246141.html   http://www.deccanherald.com/content/215612/with-100-fdi-pharma-medicines.html   http://retail.economictimes.indiatimes.com/news/apparel-fashion/apparel/india-emerges-most-attractive-investment-destination-ernst-young/26306793  http://www.lifescienceworld.in/fdi_in_indian_pharma_sector.html

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Clinical Trials in India!

Kriti Jaiswal l 17/11/2013

The Current Scenario.  The go Ahead Dilemma!

 In a recent judgment the Supreme Court of India, revoked the powers of the drug regulators in the country sighting several irregularities which were considered serious in nature.  The judgment which came in January has put the Pharma industry in jeopardy as many as 162 clinical trials are awaiting approval from the health ministry which has been barred from giving any approvals by the SC.

Death toll resulting from clinical trials was put at 2644 for the past five years. Around 11792 adverse effects were also recorded in this period. This number excludes the deaths. 506 cases of adverse effects were directly related to the clinical trial. The research firm Frost and Sullivian puts the cost of the Indian pharma industry to be 500 million dollars which is expected to grow by 2016 to one billion dollars.  A move to stop clinical trials in India would mean firms would start looking for other favorable destination for clinical trials like Singapore and Malaysia.

 The Health Ministry on the other hand is banking on the recommendations made by Ranjit Roy Choudhary committee and the amendments to Drugs and Cosmetics (Amendment Bill) of 2013 to prevent a shutdown like scenario of the clinical trial industry. The judgements have caused a flutter in the pharmaceutical industry and are leaving an unsure future for clinical trials in India. The judgments were announced after the SC heard a public interest litigation filed by an Indore based NGO, in January this year.

 The above situation explores the complex relationship between the clinical trials and law. India is a hot destination for clinical trials not only for home grown pharma but also for other countries like the US which has since withdrawn in the wake of tougher regulations and stricter implementations. India is the leading producer for many cheap drugs and vaccines which are in huge demand worldwide. If the chain is pulled on clinical trials, it would affect the industry to a great extent. Whether this would hamper innovation and invention in the field of drugs and medicine is yet to be seen.  Industry awaits the decision keeping its fingers crossed.

The Supreme Court has declared that any trial from now onwards would have to undergo three layers of inquiry before getting the final approval. The court has blocked the earlier approved 157 clinical trials saying that such trials should help the people of the country and not others. The three tier scrutiny system comprised of New Drug Advisory Committee, technical committee and apex committee. The stringent norms also demand that the trials on patient be video recorded and preserved.

The three tier system is a tougher method of regulation as only five trials were approved under it, between January 1 to August 31. The five trials are allowed on the condition of audio and video recording of the trial, taking informed consent of the subjects. The required documents have to be presented to the court while maintaining the confidentiality and privacy of the subjects who have participated in the trials. The apex court has come down heavily on the practice of paying the investigators by the pharmaceutical companies, as this may seriously come in the way of honest discharge of their duties.  The Court took notice of the fact that if such practices continued then adverse events would not be reported, and cover up would go on the sly. The court maintained that a panel of independent investigators should be set up by the government. These investigators should be paid by the government itself, ruling out any corporate interference.

Thus the current scenario depicts strict regulations which are expected to take care of the participating subjects and also control the kinds of trials approved. Whether these measures and norms succeed in preventing deaths on trial is yet to be seen.

Sources:

http://www.livemint.com/Politics/VDBSdIqvHPd92OtTQ6Nx8I/Ministryprepares-response-to-SC-query-on-clinicaltrial.html http://www.indianexpress.com/news/supreme-court-blocks-157-clinical-trials-says-must-follow-new-regime/1185664/ http://www.igovernment.in/site/sc-orders-v-recording-new-drug-clinical-trials

Technology Tracks

BioAsia 2014 brings together Science-to-Business bridges for the biotechnology industry, for driving innovation in biotech industry through its “Technology Tracks” and to help you put technology in the development relay across the world through co-development opportunities & to build capabilities to break resistors for smooth flow of technology and collaborations.
Visit www.2014.bioasia.in for more details.

BioAsia 2013 saw participation of Spain as a “Country Partner” wherein a delegation of Spanish Industries & Institutes was witnessed. In a special address, Ms Carmen Vela Olmo, Minister of State – Research, Development & Innovation – fromGovernment of Spain said “For Spain, participating in this well established forum focusing on biotechnology has been considered a priority in order to give continuity to our joint bilateral efforts with our Indian counterparts. The Spanish delegation comprising of leading research institutes, companies and technology centers has firm interest in India at the forefront in diverse fields of biotechnology and its applications and we are confident that BioAsia will offer a great networking platform to all the participants.

BioAsia 2014 to witness participation of over 50 countries. Visitwww.2014.bioasia.in for more details.

Dr. Freda C. Lewis-Hall, M.D, FAPA has been the Chief Medical Office of Pfizer Inc. since May 2009 and has been an Executive Vice President since December 2010. Dr. Lewis-Hall has extensive leadership experience across multiple functional areas in the pharmaceutical industry.

Technology tracks

BioAsia 2014 brings together Science-to-Business bridges for the biotechnology industry, for driving innovation in biotech industry through its “Technology Tracks” and to help you put technology in the development relay across the world through co-development opportunities & to build capabilities to break resistors for smooth flow of technology and collaborations.

Block New Dates!

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change cal-3

The Organizers of BioAsia hereby notify that the dates for BioAsia 2014 have been shifted to February 17 – 19, 2014 (from earlier dates of Feb 13-15, 2014). We are extremely pleased to inform that the change is in light of the confirmation from a highly renowned Nobel Laureate besides some luminaries of the sector.

BioAsia 2014 remains the same exclusive, focused event with even bigger and better opportunities. Don’t forget to add the new dates to your calender and we look forward in welcoming you in Hyderabad!