Yesterday, I happened to see a very interesting article on a website . Though I could just read excerpt as it was a paid article but the concept itself was very new in its approach. The article talked about the patients veto power in the participation of clinical trials. At the first glance I was baffled about the approach and gone weary but later as I put a second thought over it, I realised that it was even more than worth to be discussed and think off.
The article described the very raging concept arising these days about patient denial towards their participation in Clinical Research. A food for thought.!! The more you think more you get perplexed . It seems like entangling in web with no way out. Any Clinical Research on present patients is conducted for the welfare of forthcoming and future generation. So, in no case it gets futile and waste. The person participating in Clinical trials are almost equivalent to army soldiers who fights for their country without caring for their lives. And, to fight for safety of one’s country is obligatory. But then contradiction is-sparing few (like Great Britain) almost all the countries leave it up to the consent of people only whether or not to join the army. Henceforth, it doesn’t stands as a mandatory duty of any citizen of a country.
Connecting with this burgeoning argument the idea is- patients can’t veto their participation in the Clinical Trials. In no circumstances they can pull off from study unless and until authorities decides to do so. Or simply some of the others want it to attach it in fundamental duties of citizen for their active participation whenever need be.
A clinical Research as we all know encompass around four stages where an existing or entirely drug is tested in different stages upon animals, volunteers, patients , healthy human being etc depending upon the stage of the clinical trial
With human life at stake, the arguments of ‘to veto’ or ‘not to veto’ becomes too critical an issue to be wind up mere with the passing comments. Here all are invited to think of it and read it seriously and post what they think about these kind of ongoing trends of diminishing the individual freedom or is it making them more important by involving them directly for country’s growth. Is it a test of how patriotic are you or….?
Go CDA ! Get Global !!
Big Wait!! - But better late than never. The crux of centralizing drug authority to meet the global standards seems to get resolved in the months to come. A major issue that was resurfaced time and again since independence in Pharmaceutical Industry since its evolution is ready to gain the benefits in the global market.
CDA or Central Drug Authority, in real terms will be a major breakthrough for pharmaceutical industry in India, as it will open Global opportunities for India. Under CDA , a chairman will be appointed with three to five members with comprehensive powers at national level to control and regulate the pharmaceutical affairs as per the drugs and Cosmetics(amendment) Bill 2007. The bill to be brought up in upcoming winter session of parliament will empower and strengthen the Drug regulatory Authority by centralizing the licensing authority in the hands of chairman in parallel with global standards.
With the proposed Structure of Drug Regulatory Authority, a plethora of Global opportunities will prop up. These opportunities will cover, contractual manufacture (agreement for global manufacture of pharmaceutical products in compliance to the international standards), contractual research and development including formulation development, clinical research, collaborative clinical trials and customized synthesis, services like analytical method development and validation, clinical data management, ancillary equipment and material production, and manufacture of packaging material. India is a hub for contractual manufacturing process of pharmaceutical products due to its cheapest manufacturing cost across the globe. Thus, the licensing being centralized, Vaccine manufacturing units in India will gain the most. Only 15 countries around the globe producing vaccines hold Licensing of Vaccines on Global Standards. India will get the cutting edge over others once CDA get formulated as India holds 14 units who manufactures vaccines. While figure for other countries producing vaccines merely reaches to a high of maximum 5 units.
The CDA will now have a chairman with not more than five members but at least three members , to be appointed by Central govt. with the defined criteria for the qualification and procedure of appointment. The CDA office will be maintained at Delhi and all the existing power of CDSCO to be shifted to CDA itself. DCGI (Drug Controller General India) will then work under Chairman with additional DC(I) appointed separately both in AYUSH and Drugs. Under this will come ten departments to be controlled by DCGI and they will include Regulatory affairs, Imports, New drugs, Biotechnological Products, Pharmacovigilance, Medical Devices and Diagnostics, Organizational Services, Training, Quality Control affairs and legal and Consumer affairs.