Banned But Available

A number of drugs that are banned abroad are freely available in the Indian market. Why? At what cost? Who decides to let them be? Sapna Dogra takes a closer look.

Physicians need to update themselves continuously on the new adverse effects of drugs Dr Mira Shiva Director, Rational Drug Policy, Voluntary Health Association of India

Internationally banned drugs, some of them known to have serious side-effects, are readily available in the Indian market. Last year, Merck announced a worldwide withdrawal of their molecule rofecoxib, branded as Vioxx. In India however the drug was sold with impunity, and despite the litigation, warnings and media coverage of the adverse affects of the drug, it continues to be sold.

Recently, in relation to the ban on Vioxx, the government issued an order to ban another Cox-2 drug, Valdecoxib. Nevertheless, this drug is also being stocked and distributed by many chemists. It is not the chemists pushing the drug, it is the doctors prescribing it to their patients. "Everyday on an average we get five to six prescriptions for the drug," says Ajay Pal Gupta, Vice-President, Retailers and Distributors Chemists Association.

In the case of Vioxx, the drug is actually banned in India, but is being sold against the law. But, there are a number of other drugs that have got a red light in other countries, but are allowed to circulate freely in the Indian market with government approval. Explains A B Ramteke, Deputy Drug Controller General of India (DCGI), "It is not necessary that a drug which is banned in other parts of the world should be automatically banned here." Some industry specialists like Dr Rajesh Pande, Head, Critical Care, Fortis Hospital, agree with this stand.

Process of banning

According to Ramteke, the Drugs Technical Advisory Board (DTAB) is the final authority on imposing a ban. An executive committee examines the harmful effects of the drugs and reports the results to the DTAB. If any drug is found to have harmful side-effects, the government issues the ban order and all manufacturers and wholesalers are asked not to stock the particular medicine. The DCGI notifies all state drug authorities, chemist associations and manufacturers about the ban on the drug. Authorities are instructed to carry out inspections. Licences of chemists stocking banned drugs can be revoked under the Drugs and Cosmetics Act, Ramteke says.

India is a vast country with multi-ethnic population. It is therefore necessary to have a viable Adverse Drug Reaction (ADR) data capturing system. The Indian Central Drugs Regulatory Authority has therefore set up a vibrant pharmaco-vigilance programme in the country. One of the functions of the programme is to assess the benefit, harm, effectiveness and risk of medicines; encourage their safe, rational and proper use; and improve patient care and safety in relation to the use of medicines and all medical and para-medical interventions. According to Pande, the pharmacovigilance programme has experts on board to decide whether a particular drug should be banned or not.

To ban or not to ban

Even countries such as Bangladesh have banned Nimesulide for both adults and children, but the Indian government has turned a blind eye to the entire issue Dr C M Gulati Editor, Monthly Index of Medical Specialities (MIMS)

In spite of several initiatives, the authorities have allowed a number of internationally disapproved drugs to circulate in the Indian market. The widely-used pain-killer nimesulide is banned internationally but available in India, says Dr C M Gulati, Editor, Monthly Index of Medical Specialities (MIMS). The drug is known to cause liver failure, and the European Agency for Evaluation of Medicinal Products (EMEA) has prohibited the use of the drug in children below 12 years. Earlier, countries such as Finland, Spain and Portugal suspended the use of nimesulide in the wake of reports of its serious adverse effects on the liver. Even countries like Bangladesh banned this drug for both adults and children, but Indian Government has turned a blind eye to the issue, complains Gulati. He states that the side-effects of nimesulide are more severe than those associated with rofecoxib, but it is still being allowed in the market.

A proponent of nimesulide from the industry claims that there has never been an application for its registration in the US. So, the question of its ban there does not arise. EMEA is only a recommending body and not a regulatory body. However it raises alerts which are required, according to many people in the industry. It is a different matter that the Delhi High Court discounted the drug for the lack of studies or data to support its ADRs.

Since the drugs are not banned, chemists and stockists have no reason not to sell them or warn users about the controversy that engulfs the medicines. So though most pharmacies in Delhi have cleared their stocks of the recently banned drugs like Vioxx and Valdecoxib, they continue to stock other medicines which are banned elsewhere in the world. These drugs include cisapride, furazolidone, nimesulide and oxyphenbutazone. "Since the DCGI has not banned them they will be available," says Gupta matter-of-factly.

A surprising lack of knowledge

Why do doctors continue to prescribe banned medicines? The reason, most people say, is lack of awareness. While doctors in big hospitals are aware of the ban on the drugs, many private practitioners do not keep track of the latest developments. Gupta suggests that the drug control authorities fail to inform all the hospitals of the status of medicines.

According to the IMA Secretary General, Dr Vinay Aggarwal, DCGI informs IMA about the ban order, and they update the doctors through the IMA newsletter and JIMS. The IMA newsletter has wide reach, and is fast in disseminating information to state branches from where it is accessible to doctors.

Doctors also get to know about these developments through the British Medical Journal and the New England Journal of Medicine, informs Dr Pande. However, Dr Aggarwal feels that the system of DCGI is not systematic, and that it can be improved if such information is advertised in newspapers.

While some believe the information must be pushed by the government, others consider it important for doctors to play an equally active role in acquiring the information. "Physicians need to update themselves continuously on the new adverse effects of drugs," says Dr Mira Shiva, Director, Rational Drug Policy, Voluntary Health Association of India.

Other problems

Shiva agrees that the laxity on the government's part and the selfish interests of the manufacturers in not banning drugs is a concern. Nevertheless, she believes that the main problem is that of irrational doses rather than the availability of banned drugs. Then there's another problem: combination drugs, wherein a formulation has two or three ingredients, giving rise to drug reactions along with drug interactions, informs Shiva. Lack of ADR monitoring centres in the country leads to little reporting of adverse reactions, so some drugs find a foothold in the market undeservingly. The establishment of a National Pharma-covigilance Commission and other planned changes in drug regulation are positive steps, but much remains to be done, Shiva adds.