The controversy over the availability of "globally banned drugs" in the country is likely to continue as the central government has taken a stand that there is "no system of global banning of a drug" and the decisions are based purely on risk assessment specific to each country.
The government reiterated its position that the 11 drugs namely, analgin, cerivastatin, droperidol, furazolidone, lynestrenol, nitrofurazone, phenformin, phenolphthalein, phenylbutazone, piperazine and quiniodochlor, listed as globally banned drugs in the Monthly Index of Medical Specialties (MIMS), are permitted to be sold in India and many countries and the publication is not based on facts. The Centre clarified that the drugs continue to be marketed in the country on the basis of reviews undertaken from time to time by various expert committees after examining the benefit-risk ratio, safety and utility of these drugs in the country.
Reacting to the government stand, Dr C M Gulati, editor, MIMS India informed Pharmabiz.com that the list was not prepared by his organization but is just a reproduction of the "WHO consolidated list of products whose consumption and/or sale have been banned, withdrawn, severely restricted or not approved by governments". He agreed that "globally banned" doesn't imply that it has been banned in each and every country. "However, the WHO list is indicative of the general attitude of drug regulatory authorities across the world and their perception of the harmfulness of the drug. Allowing a drug just because it is approved in some country or other, is not a good practice", he warned.
Dr Gulati wanted Indian drug authorities to take cognizance of the fact that developed countries, all of which have banned these drugs, constitute the bulk of world drug market. "According to latest figures, world pharma market is worth US $ 430 billion of which US share alone comes to $ 216 billion. About 25 % of what is left is from the EU. Japan constitutes of 8 % share. Thus the percentage of drugs market is very less in other countries. It is absurd to say that a drug is not banned globally if it has been banned in all these major countries and is still being used in any of the minor markets," he explained.
The central government however feels that the risk assessment pattern followed by the country is influenced by a number of factors such as the disease pattern, the varying reactions of certain ethnic groups in a given population to the drug and the availability of safer substitutes as well as the cost factor involved in the treatment of a particular disease. The government also points to the fact that administration of any drug is not absolutely free from side effects or adverse reactions in a statistically insignificant minority of the population.
Dr Gulati said that the explanation given by the government is too common and does not reflect the seriousness that is needed. He informed that the forthcoming issue of MIMS would include nimusulide also along with the list of banned drugs, as the drug companies do not market the product in major markets.
At times the explanation given by the companies can also be misleading. "Due to the prior knowledge of the harmful side effects of a particular drug, they may not apply for marketing licenses for the drug in countries where drug regulatory authorities are very strict. The companies try to sell off such products in the developing countries", he alleged. He said that this particular strategy of pharma companies would be brought before the court during the future hearing on the PIL related with the nimusulide ban is taken up.
In the case of nimusulide, the central government had cleared the drug after getting positive reports from the pediatricians across the country. The decision was challenged in the Delhi High Court, which has given time till May 26 for the Drug Technical Advisory Board to examine the safety aspects of nimesulide.