Ban of more than 344 Fixed Dose Combinations by Government. Who is responsible for unapproved combinations manufacturing in India?

Update 4:

Government move to Supreme Court seeking ban at 344 Fixed Dose combinations and overturn Delhi High Court order. Now final decision is pending.

Update 3:

December 2016, Delhi High Court Lift ban from 344 Fixed Dose Combinations after hearing pharmaceutical companies point of view.

Update 2:

Nearly 454 petitions from pharma and healthcare companies (Including Big pharma) has been filed in various court of India 

Update 1:

one mail we received from our reader regarding ban on combinations. he has very strong argue against ban but instead of all argue our team still feel it is good decision by government by banning unnecessary combinations. Few arguments, we are detailing here:

  • Indian have been habitual to these combinations. Patients who were treated by combinations of higher antibiotics, how can they be treated by single antibiotics. Single antibiotic can’t treat them, their body have become resistant against smaller and/or single antibiotics. It will be difficult to treat them without these combinations.
  • In case of single molecule, cost to the patient will be at higher side. In combination, approximately a cold syrup cost 45/- to 80/- per piece in combination but if given as independent each molecule will cost not less than 45/-. Then total cost to the patient will be not less than 135/-.
  • Pollution is main cause of diseases. If our government can’t control pollution then how could they control diseases by banning these combinations.
  • A combination is manufacturing in India from last 25 years. How can drug department feel suddenly, this combination is not safe. Without drug department approval, a single drug could be manufactured in India. If department provided approval then suddenly what happened.
  • Has Department completed adequate research about complication produce by these combinations.

Original Article:

With ban of 344 fixed dose combinations by DCGI, pharmaceutical sector is facing a new regulation and future concern of pharmaceutical sector in India. Number of articles have been written about banning of these combinations in India. This will definitely cause profit and sale loss to pharmaceutical industry but this move will be beneficial for all patients. This move will take our Pharma sector in competitive and innovation phase.

Most of developed country have single molecule policy. They don’t allow any combination then why India allow drugs in combinations. This is a serious matter of concern. Banning of these 340 combinations and pending list of mole than 6500 combinations may be a small step toward single molecule policy.

Major question is raised here that from last 30 years a combination is being sold in India and our drug control department has no concern whether it is safe or not. What it will cause damage to health of all individuals. A report says more than 20% Indian population is reaching toward serious antibiotic resistance. Are these combinations causing our body resistance toward antibiotics. A much needed debate is required.

Second question is that Is it a scam? Is bribery and money involved in approval to provide benefits to some manufacturing companies?

In India two type of Drug manufacturing approvals is provided by drug department. Drug controller general of India look after all approval for manufacturing of new drugs & combinations and state drug controller department gives approval for manufacturing of already approved drugs and combinations by DCGI.

If banned combinations was not approved by DCGI, then how can state drug controller give approval for manufacturing of these combinations. Haven’t they have list of approved combinations of DCGI molecules or they ignore all regulations and laws to provide benefits to some manufacturers. What was reason behind this is matter of investigation.

We don’t think any guilty person will be punished in this matter. But they should. They played with life of citizens. Every state appoint drug control office to look after implementation of drug and cosmetic act and rules, and take care of effective & safe medicine availability in market. If drug department is playing with health of patients then where to go for safe medicines.

Drug department take action against all manufacturing companies if their products found of substandard quality. At this time our drug department is found of substandard quality, who will punish it. Hope concerned person will take it seriously.

Third question is that why combination is always favorite for pharmaceutical companies and Doctors in India?

During pharmacy education, main concentration is at side effects and precautions of molecules. We didn’t read much about any combinations except few. But in professional life, there is no concern about whether it is single molecule or in combination. If doctors are prescribing it and we are making profit from it along with doctors then it doesn’t matter.

Every professional knows one antibiotic is enough to treat a single type of infection, then what is need of prescribing two or three antibiotic combination. Are doctors in doubt about their knowledge and education. They don’t know which infection will be treated by which antibiotic. They surely don’t know if they are prescribing combinations or more than one antibiotic at a time. They have wasted all years of MBBS. They don’t deserve to be at society highest respectable persons place.

Pharmaceuticals companies and their marketing think tank only search for how to increase sale. They always look for new molecules or combinations. If they find any in market, they want to launch it. They also has no concern whether this combination is safe or not.


Then who one has public safety concern in India…. No one…

Main reason may be that allowance of non pharma background professionals in medicine sector. Chemist, wholesaler and pharma companies owner are mostly non professionals. They don’t know about any single molecule. They only know about use but don’t know about complications causes by every single molecule. Government should  think about restriction of entry of non professionals in pharma sector.

Lot to write but who will read this. We, you or general public only. Drug authorities have no time to read these stupid articles. Most educated and profitable profession has most insensitive one.

View list of Banned drug combinations in India

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Hope you enjoyed reading this article. Thanks for giving time…

Keywords: Updates at drug ban in India, Ban of fixed Dose combinations in India
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