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DCGI may ban 619 more FDCs based on review of expert panel report

Shardul Nautiyal, Mumbai
Monday, March 21, 2016, 08:00 Hrs  [IST]

Following the Union health ministry's ban on 344 fixed dose combination (FDC) drugs including painkillers, anti-diabetic, respiratory and gastro-intestinal medicines, the pharma retail market may witness around 619 FDCs going off their shelves as Drugs Controller General of India (DCGI) may ban them in the coming months. DCGI is currently reviewing another 619 medicines out of the total 963 FDCs found irrational by a 9-member committee headed by CK Kokate.

The irrationality of the FDC was assessed based on a blind process which could determine that the ingredients used in the FDC proved efficacious and safe for the patients and the FDCs were banned taking into consideration the health prospects of the common man with focus on antibiotic resistance.

A member of the expert committee formed to assess the rationality of over 6,220 FDCs which culminated into banning 344 medicines clarified that many of the FDCs did not face a similar fate and were cleared based on the scientific documentary evidences. Actions from the DCGI office was taken on companies who did not register their FDCs with the DCGI and did not show up with the requisite documentary evidence to claim the safety and efficacy of the respective FDC in question.

The DCGI, as directed by the health ministry under 33-P had called for submitting efficacy and safety data for all combination State Licensing Authority (SLA)-approved products prior to October 1, 2012. Further the Central Drugs Standard Control Organisation (CDSCO) stipulated that such applications must be made in Form 44, as there was no format specifically available for applications of SLA-approved and already marketed FDCs.

The DCGI had earlier agreed to allow all pre-1988 FDCs to be licensed by SLAs provided proof of pre-1988 license is submitted. FDCs of vitamins, minerals, other nutrients; probiotics/prebiotics/synbiotics, antacids/enzyme formulations, cough and cold permutation combination products, topicals, and such simple FDCs should be cleared as rational in view of these being unlikely to have any concern with respect to safety concerns and being used on day-to-day basis as household products.

“The SLAs had given permission to manufacture and market FDCs, whose ingredients were already usually in use and being prescribed regularly by the medical professionals – may be even for 20 to 30 years, or more. Today, FDCs contribute 40 per cent of the Indian pharmaceutical market and in case these FDCs are discontinued abruptly, the Indian patients will be deprived of these affordable medicines and the manufacturers, retailers etc. i.e. the distribution chain, will be left with depleted stocks resulting in substantial loss, especially to the small scale sector. India is the world leader in FDCs and today, even regulated markets are seeing introduction of more combination products progressively. Hence the bias against FDCs, if any, would be a retrograde step and negate the great achievements made by the Indian pharma manufacturers,” an IDMA submission concluded.

Government has banned common household medicines Crocin Cold and Flu, D-Cold Total, Sumo, Oflox, Gastrogyl, Chericof, Nimulid, Kofnil, Dolo Cold, Decoff, O2, paediatric syrup T-98 and TedyKoff, as part of its decision to stop the manufacture and sale of FDCs.

A fixed dose combination contains two or more drugs combined in a fixed ratio of doses, available in a single dosage form. The health ministry, had, in a notification on March 12, banned nearly 344 FDCs with immediate effect, following recommendations of an expert committee formed to examine the efficacy of these drug combinations.

According to research firm AIOCD AWACS, the top five therapeutic categories to be impacted include anti-diabetic drugs, respiratory drugs, analgesics, anti-infective and gastro-intestinal drugs. Market estimates reveal that the ban impacts over 2700 medicine brands. While Abbott Healthcare will be worst hit, with an annual loss of Rs.485 crore, other companies including Lupin, Sun Pharma, Glenmark, Wockhardt, Aristo and Intas would also bear the brunt.


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Altaf Hussain Mar 29, 2016 10:44 PM
Very glad that Govt has finally waken up to ban stupid FDC drugs available only in India and nowhere else in world. Why should public at large suffer from irrational medicines because pharma lobby needs profits. And, why blame Ayurveda and get political on this issue, when scientific evidence is lacking on these FDC drugs.

And very smartly pharma had taken local state govt approvals for manufacturing licence since years without any expert review by doctors. And dcgi had approved these irrational FDC earlier to subject expert committee in the approval process.

Nothing should be sold without scientific evidence, be it Maggi or FDC drugs or Ayurveda or Unani or Homeopathy or Siddha or any damn system of health in this world including India.

Hats off to this evolving Indian scenario. Bless our children with safe and efficacious medicines and food just like in well regulated and developed countries.

Pharma lobby needs to learn to make good sound FDC drugs instead of complain
kailas Mar 25, 2016 10:36 PM
It was started previously to ban ,CDSCO/FDA -
For safety of patient decision is correct ,

Branded formulation by Commercial manufacturers make sufficient profit
Time came to strictly action by CDSCO
for safe of enduser


kailas Narale Mar 23, 2016 12:28 PM

This process was started 2012
better to ban FDC 344 and study other FDC possible to ban

slightly change formulation allow as Brand It will stop and common man will get proper medicine
what ever CDSCO/FDA doing well for safety of patient

Late but correction action by Health dept


Dhrub Tripathi Mar 22, 2016 11:11 AM
That types Formulation to many loss of body in protein & enzymes and lack of daily activity.
I have suggest to develop only single molecule dosage with technical modified as relief patient according disease.
I have also know scientific modification but i have not a platform.
Prakash Mar 21, 2016 8:27 PM
This Govt is banning everything that is not made by its half naked cronies. The message is: Die and go to heaven. No one promised you Achchhe Din here on Earth. 120 Crore people have received babaji ka ----- Jai Gurudev!
Laishram Premananda Singh Mar 21, 2016 2:01 PM
This is the last resort to push uncontolled ayurvedic medicines in the market like ban of maggi before.
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