India is a significant player in the global marketplace. As per the UNICEF’s report “India is the Largest Supplier” with about $558 million worth of services and supplies. India has consistently been the largest supplier since 2007 and is the largest supplier to UN groups. UNICEF has recognized India’s contribution to global air, and international groups have lauded India’s role in increasing access to medicines in the developing world.
Paul Cawthome (MSF Access Campaign Coordinator-Asia) highlighted the worldwide dependency on India as a drug supplier best and said ‘it comes as a great relief to millions around the world who depend on a continuous supply of Indian generic medicines’
Now it is the high time that India really needs to be a full participant. With sales of more than $26 billion, India’s drug sector has grown into the U.S.’s second-largest supplier of prescription and over-the-counter medications, behind only Canada.
You already know that in March 2013 the FDA received approval from the Indian government to add additional investigators to its team in India. The head of the Food and Drug Administration said recently that her agency will add more inspectors in India to better monitor drugs from the country’s burgeoning pharmaceutical industry, even as her agency also seeks closer cooperation from Indian regulators. FDA Commissioner Margaret Hamburg suggested during a press teleconference that India’s Ministry of Health and Family Welfare needs to become more engaged in regulation on both a domestic and international scale.
FDA Commissioner spoke with reporters following an eight-day trip to the Southeast Asian nation, where she met with Indian health regulators and drug industry executives. Hamburg said the FDA will expand to 19 staffers in India from its current 12, as the U.S. tries to assure the safety of medications.
Several journalists for Indian publications questioned whether the FDA is specifically targeting Indian companies for enforcement. But Hamburg rejected that assertion, saying that the agency takes action against all companies that violate FDA standards, regardless of where they are based.
“If a company is manufacturing a product for sale within the United States, they have to meet our regulatory standards and requirements,” Hamburg said. “What’s happening in India is consistent with what happens in the United States and throughout the world.” Source
What TGI Recommends:
As a thought though… Adopt “Hyper-Quality-Loop” Model with a slogan “PROMISE made by Clinician, is the PROMISE kept by Physician”. It is a kind of MUST in Indian scenario and other similar cases. You already know that drug discovery and developing a molecule costs about $2 billion. Moreover significant efforts are made at every level of the discovery and development and, at clinical studies many sacrifices are made to bring a potential molecule to the end user. In this context, Physicians could play a significant role in identifying the quality compromised drugs well before such drugs are unknowingly prescribed to their patients. This additional step, though it may mean some additional spending, to tighten the loose ends in the system in order to more complete the quality loop. This will help control defects, if any, especially for example in the supply chain that the actual manufacturer may not be completely aware of. Most patients, if not all, not in a position (lack of will, knowledge or awareness) to verify or less bothered about the quality and quantity of the medicines that are administered. Patients and their Caretakers are innocent and they completely trust their GP or the expert and rely on them for the treatment. Therefore, physicians could play a major role by taking this as an opportunity to serve their patients better and win more trust.
Following is the pictorial that is self-explanatory.
…PROMISE made by Clinician, is the PROMISE kept by Physician
Throw some light on the following points….could be useful:
- Conduct a vulnerability ASSESSMENT of critical control points
- Find out who has ACCESS to critical control points (storage, packaging, labels etc)
- MONITOR the entire supply chain (good system in place means good protection to your brand)
- Provide documentation of compliance to regulatory authorities (internal and external)
- Share all this info with PROMISE
Taking into the account INDIA’s culture, traditions, values and, knowledge and talent base, India will always continue to remain as No.1 in sharing knowledge (Science, Technology, Engineering, Management) and products that the world is in need indeed.