India remains the largest supplier country, says UNICEF

· TGI - Regulatory

UNICEF recently released its Supply Annual Report for 2012: India is the Largest Supplier. The Report is an yearly assessment of the UNICEF supply programme which provides women and children with an equitable access to life-saving supplies. The UNICEF Supply Division recently moved its base to Copenhagen, Denmark with a state of the art warehouse to ensure timely reach of life-saving supplies all over the world. Its activities in influencing markets, innovation and supporting supply chain strengthening continued apace during the year, with substantial achievements in terms of reduced prices, reduced supply chain costs and the introduction of new products. Regarding encouraging innovation, the program has several innovation projects in the pipeline. These are mainly aimed at development of low-cost diagnostic devices that make accurate diagnosis under extreme environmental conditions.

India was the largest supplier country in 2012, with  $558 million worth of services and supplies. Belgium came in second, contributing less than half of India’s supplies with a figure of $349 million.

Serum Institute of India Ltd supplied vaccines/biologicals worth $254 million dollars, making it the largest supplier in India.

Mylan Laboratries (pharma company) is at a distant second spot, with supplies worth $ 45 million.

Other significant suppliers are Ranbaxy Labs, Hetero Labs, Aurobindo Pharma, Haffkine Bio-Pharmaceutical Corporation, Biological E and Micro Labs Pharma.

UNICEF makes great efforts to buy supplies where they are used. Almost two-thirds of the top 33 supplier countries are countries where UNICEF has development programmes. India has consistently been the largest supplier since 2007. UNICEF has recognized India’s contribution to global aid, and international groups have lauded India’s role in increasing access to medicines in the developing world. In fact, India is not only the largest supplier to UN groups, but also to the Mêdecins Sans Frontieres (MSF) and International Dispensary Association. Indian medicines are also extremely affordable. Anti RetroViral (ARV) treatment in Europe was $10,000 per patient a year, until Indian manufactured drugs brought it down to $95 patient a year.

India happens to be the largest supplier of generic ARVs to low and middle income countries. Paul Cawthome (MSF Access Campaign Coordinator-Asia) highlighted the worldwide dependency on India as a drug supplier best, when he said : ‘It comes as a great relief to millions around the world who depend on a continuous supply of Indian generic medicines that the Indian Supreme Court has ruled against Novartis.’ In another instance, when Big pharma threatened legal action against the South African government in the latter’s efforts to bring down prices for HIV-AIDS treatment, Indian pharma major Cipla stepped in and offered to supply drugs at just $350 per patient per year. This exposed inflated rates of medicines in the global market, and the case against SA government was withdrawn.

These scenarios demonstrate India’s inclination to increase global accessibility to medicines. Hopefully the efforts will also be emulated by other nations in the wake of rising healthcare costs, especially in the developed countries. Source

To explore the need and prospects for greater international regulatory harmonization for drug development, the IOM Forum on Drug Discovery, Development, and Translation hosted a workshop on February 13-14, 2013. Discussions at the workshop helped identify principles, potential approaches, and strategies to advance the development or evolution of more harmonized regulatory standards. This document summarizes the workshop.

 FDA strives to ensure that regulated product manufacturers, wherever they may be located, comply with standards and regulations for their products provided to US consumers. India, as the second largest provider of finished dose products to the U.S. with almost 10 per cent of the market, has for many years been a consistent provider of low-cost and quality medical products for many countries of the world. Our presence in India allows us to better collaborate with our Indian regulatory counterparts and enables us to leverage our combined resources, harmonize science-based standards and increase regulatory capacity, says FDA. In doing so, FDA continues to ensure that medical products moving in international commerce are safe, effective, and of high quality.

The FDA will increase its activities in India.  It is exploring the opportunity to open an additional office in Hyderabad. In March 2013, the FDA received approval from the Indian government to add seven additional drug investigators (to its team) in India. FDA said that its India-based staff, through their interactions with industry, work on identified challenges so that industry will take the necessary steps to self-correct.  It will work through a variety of methods, including scientific reviews, inspections of facilities and post-market surveillance,

FDA has been transforming from a domestically-focused agency to a proactive, global public health agency in order to carry out the mission more effectively in a world where trade – and product safety and quality – have no borders.  The regulation of medical products today requires a global effort, and that’s why the FDA has opened offices and posts around the globe, including India. The health watchdog said that many Indian drug-makers are well-compliant with the rules in the US, to whom India is the second largest drug exporter, while it is ready to provide guidance to others that “present problems and challenges”.

 FDA remains very confident that many companies understand and have implemented Good Manufacturing Practices (GMPs).  We also remain vigilant and will take appropriate action if, or when, lapses occur, says FDA spokesperson  Christopher C Kelly.  Source

“With an integrated effort and cooperation India will continue to remain as the largest supplier of low cost, high quality medicines to the world.”

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