New Delhi, Sep 14 (KNN) Many micro, small and medium enterprises (MSMEs) manufacturing drugs are fearing massive impact due to Ministry of Health and Family Welfare’s (MOHFW’s) decision to prohibit the manufacture, sale or distribution of 328 Fixed Dose Combinations (FDCs) with immediate effect.

In a blow to both domestic and foreign pharmaceutical firms, the central government has banned a total of 328 FDC.

Manufacture, sale or distribution of six FDCs subject to certain conditions is also restricted by the Ministry.

Speaking to KNN, Deputy Secretary General of Indian Drug Manufactures, T.R. Gopalakrishnan, said, “These drugs should have not been allowed at the first place. Some of the drugs could have continued with no harm.”

The government’s decision to ban 328 FDCs will impact the manufactures’ sales and to revive it they may increase the cost of the drugs.

Raining concerns for the MSME manufacturers, he said “Manufacturers will have to pay the price of this ban. However, the decision will be respected.”

Earlier, in 2016, when 344 drugs had been banned, some companies challenged the ban in various courts including Supreme Court on the grounds that they were not given an opportunity to present their case. On their demand then 15 of those had been exempted and six were allowed on certain conditions.

In July, an expert panel of the health ministry, after reviewing 349 fixed drug combinations (FDCs), had recommended that 343 of them should be “prohibited” and the remaining six should be “restricted or regulated”.

In December last year, the Supreme Court had directed the health ministry’s expert body, Drugs Technical Advisory Board (DTAB), for a fresh review of safety, efficacy and therapeutic justification of these 349 FDCs. Therefore, the DTAB formed a sub-committee, which studied the issue and submitted its recommendations.

Among the brands that are affected by the ban are popular drugs like the painkiller Saridon, the skin cream Panderm, combination diabetes drug Gluconorm PG, antibiotic Lupidiclox and antibacterial Taxim AZ. 

The ban, however, has been lauded by health activists worried about growing antibiotic resistance due to the misuse of medicines.

FDC means a combination of two or more drugs in a fixed dosage ratio. Some of the banned drugs were: Cefixime + Azithromycin, Ofloxacin + Ornidazole Suspension, Metronidazole + Norfloxacin, and Paracetamol + Propyphenazone + Caffeine (trade name Saridon). (KNN/ JM)