New Delhi: Top 20 companies in United State of America are the member of billion dollar FDC club and name of those members are Novartis, Merck, GSK, Astra Zeneca, Sanofi, Reckitt-Benckiser, Boehringer-Inglheim, Pfeer, Gilead to name a few. Interestingly US firms are still importing few products of 344 ban FDC to name a few is clobetasol propionate + gentamycin + Tolnafate + Iodochloroquinone + ketaoconazole cream.
Who is bigger, Kokate decision or Drugs and Cosmetics Act? In court both are fail because industry has done nothing wrong, they have legally valid license and manufacturing as per the law of the land. It is also clear that DCGI cannot over rule state approval.
Kokate committee examined 6,220 FDCs and deemed 963 to be irrational, now recommended to ban 344 in phase-1 and rest would be banned in next phase-2. It is very sad to say rational and irrational combination has not been defined globally in law book. How come Kokate committee termed 963 FDC irrational?
Dr. C. K. Kokate is a pharmacognosy professor and he deals with plant ingredients. I wonder on what grounds he has studied 6, 220 FDCs to claim irrational. Pharmacologist is the right person to deal with medicine. His chairmanship for the committee itself can be questioned in HC, Rajmauli, IDMA Telangana.
You can ban approved drugs on the basis of adverse drug reaction data and there is no data available with Kokate committee. Government should implement Pharmaco vigilance or safety vigilance on all medicine available into the market place. Currently CDSCO suggests to submit PSUR (periodic safety update report) for new drugs means up to 4 years from the date of approval from CDSCO. It is also wrong vigilance on medicine should be mandatory for full product life cycle.
Current sale of Jyoti agarwal from Ahmedabad is 4 lakh after ban of 344 FDC and earlier it was 1, 25,00000 rupees per month. He fired all 55 employees at a time and others are doing the same thing. Industry degrown by 10% in one go and it will go down and down.
Rational FDC law should be in place to give clearance to old approved FDC and industry can apply for new innovative FDC. Industry is ready to invest but they are scary whether they will get approval or not because law is not in place and uncertainty is there in the mind of manufacturers.
We are 1/6th population of the world and we should be pioneer in introducing in approval criteria for innovative FDC under the Drugs and Cosmetics Act. Only 65 million populations (United Kingdom) and 350 million populations (USA) are leading world and more than 1400 population is following them in pharma sector. Now, Indian pharmaceuticals companies will lead the world if government will come up with industry friendly steps.
Dear Modi, take up this issue seriously, your team is working against “Make In India and Innovation in India. Your team is autocratic in approach and legally wrong and they have lack of knowledge to deal with medicine.
Mohammad Shahbaz Alam, Email:email@example.com