HEALTH MINISTRY BAN ON 344 DRUGS IN INDIA:

HEALTH MINISTRY BAN ON 344 DRUGS IN INDIA:

by Levin Thomas

The Health Ministry of India has banned 344 fixed drug combinations through a gazette notification issued on March 2016. These include several common cough syrup solutions, analgesics and antibiotic combinations, many of which are sold over the counter in India. The list of banned drugs included some widely used products such as Vicks action 500 tablet made by Procter & Gamble and Pfizer’s Corex syrup.

The ban, which came into effect immediately, followed recommendations of an expert committee formed to examine the efficacy of these drug combinations. A fixed dose combination or FDC is one that contains two or more drugs combined in a fixed ratio of doses and available in a single dosage form. Fixed drug combinations have mushroomed in the market as companies in their quest for newer products — and often to beat price control by mixing and matching ingredients into a single molecule to market them as newer remedies.

The CDSCO has given 2 main reasons for the ban:

1.      The drugs were likely to involve risk to human beings while safer alternatives were available.

2.      The drugs were not found to have no therapeutic justification.

The health ministry's decision is in line with recommendations of an expert committee headed by Professor CK Kokate, constituted in 2013 to evaluate efficacy and safety of FDCs. The committee, which also had members from leading healthcare institutions including AIIMS, also recommended that combination drugs be classified into four categories and different clearance norms be specified for each. The categories included those in which one or more ingredient has not been approved for use in India, those which have not been marketed in India but its constituents have been approved and marketed individually in the country. It also proposed stricter marketing clearance routes for such medicines. So far about 6,600 FDCs has been reviewed​ by the Committee and have classified them under four categories of irrational, require further deliberations, rational and require additional data generation. “Under the irrational category, there were 963 FDCs, out of which 344 have been announced, and the list has been dismantled. The list of drugs in that which ‘require further deliberations’ category, is under scrutiny and is expected to come in six months. The DGCI has now submitted a “B” list of FDCs to the Kokate committee. Out of the 1,200 FDCs mentioned in the list, 8-10%, i.e. around 120 drugs, would fall under the banned category

Though approval by the Central drug regulator, drugs controller general of India (DCGI) is mandatory for FDCs, many unapproved formulations were thriving with a weak monitoring mechanism at state level. The main aim of the Centre's ban was to eliminate such medicines. A study published in 2015 in journal PLOS Medicine pointed that over 12% of nonsteroidal anti-inflammatory drugs (NSAID) FDCs sales volume contain drugs that have either been withdrawn from the market or have had their use restricted. The paper was based on a study done in just four therapeutic areas including analgesia, anxiety/ depression and psychosis. Besides, many NSAID combinations available in India contain muscle relaxants and enzymes that have been approved as a single dosage form in the US and UK but never as a fixed dose combination. Many of these drugs which have been available in India for decades are already banned in most parts of the world including in the US and UK.

The ban has taken the pharma industry by surprise. According to estimates, these companies are likely to suffer immediate loss of Rs 1,000 crore. However, the annual loss is pegged at Rs 4,000 crore. This could even go to Rs 10,000 crore, if more drugs are banned. The size of the pharma market in India is estimated to be Rs 1 lakh crore. The BSE Healthcare Index, a broad indicator of pharma stocks has dropped 3.44%. BSE Healthcare Index has 15 pharma stocks, including Cipla, Glemmark, Lupin and Torrent Pharma. The drop in the domestic revenue will only add to the woes to the Indian Pharma industry. Experts have already warned of a bleak export growth for the pharma industry for the 2017 fiscal year. The industry is set to question the basis of the ban and seek judicial intervention.

LIST OF NEW DRUGS APPROVED IN INDIA FROM 01-01-2016 to 31.03.2016

Sl.No	Name Of Drug	Indication	Date of issue
1	Nintedanib soft Gelatin Capsule 100/150mg	For the treatment of Idiopathic Pulmonary Fibrosis (IPF).	11.03.16
2	Cisatracurium Besylate Bulk & 2mg/ml injection	As an adjunct to general anaesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery.	14.03.16
3	Fomepizole Bulk &1.5gm/Ampoule	As an antidote for Ethylene glycol or Methanol used poisoning or for use in suspected Ethylene glycol or Methanol ingestion, either alone or in combination with hemodialysis.	14.03.16