Breaking the faith

Breaking the faith

Inspite of a rapidly growing pharma and health industry, several internationally banned drugs are easily available in the country. Sushmi Dey reveals more on the controversy

The next time you go to your chemist to buy your prescription medicine or an over-the-counter (OTC) drug, make sure you check whether the product you are about to purchase is not banned for serious side-effects. Several drugs which are internationally banned for serious side-effects are still readily available in the Indian market. For instance, despite the worldwide withdrawal of Merck’s molecule Rofecoxib, branded as Vioxx, a few years ago, the drug continues to be sold with impunity in India, despite extensive litigation, warnings and media coverage on adverse impacts that the drug has on patients.

In relation to the ban on Vioxx, the Centre issued an order banning another Cox-2 drug, Valdecoxib. Nevertheless, this too is being stocked and distributed by many chemists.

In an attempt to ascertain availability of safe medicines, the union health ministry had appointed a sub-committee last year to check into the circulation of banned drugs in India. However, industry experts feel that chemists are not to be solely blamed for the problem as there are many doctors who continue to prescribe many such banned drugs.

Blame whomsoever, but it is a fact that inspite of the high growth rate that the Indian pharma industry is reflecting presently, there are many loop holes in the system attracting global criticism, and availability of several banned drugs is one such example.

While Vioxx is actually banned in India and is illegally sold, there are several other drugs that are banned globally, but are still legally available in India. Explains S W Deshpande, Director General, All India Drugs Control Officers’ Confederation (AIDCOC), “Criteria for banning a product are individual to every country.” Sandeep Nangia, President, Retailers and Distributors Chemists Association (RDCA), seconds this, “There is no hard and fast rule that a drug banned internationally should be banned in India.”

Process of banning

Dr Chandra M Gulhati, Editor, Monthly Index of Medical Specialities (MIMS)

Ironically, while the safety and efficacy of a drug is ascertained as per Schedule Y of the Drugs and Cosmetics Act, globally too there is no system of banning drugs by any organisation or regulation. “There is no written, transparent, verifiable, accountable procedure to ban drugs in India,” says Dr Chandra M Gulhati, Editor, Monthly Index of Medical Specialities (MIMS). However, according to Gulhati, Drug Controller General of India (DCGI) has the authority to ban drugs in India.

According to Deshpande, DCGI imposes the ban under Drugs and Cosmetics Act, based on the adverse drug reactions (ADRs) and scientific evidence reported by Drugs Technical Advisory Board (DTAB). 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. “Before the DCGI issues a notification, manufacturers and wholesalers are informed so as to allow them one to two months of time to plan their future,” informs Deshpande. The DCGI also notifies all state drug authorities, chemist associations and manufacturers about the ban on the drug.

And what if someone is found stocking these banned drugs? “The matter is investigated and chemists and manufacturers are held answerable for stocking banned drugs,” says Deshpande.

Housing banned drugs

India is still home to many of the drugs that have been banned in developed countries. There is a huge international debate and disagreement on availability of such drugs in India. Experts feel that inspite of several initiatives, authorities have allowed several internationally disapproved drugs to circulate in the Indian market.

“Other countries have active Food and Drug Administrations (FDA) and everything there is based on scientific evidences. In India, we do not go to that extent. All unnecessary combinations are banned in the world market. They have banned it not because they do not like it, but because they have scientific evidences against the drug. If US and UK have banned these drugs because they are harmful to their population, there is no reason to believe that these drugs are not harmful to Indian population, unless it is proven otherwise. When FDA in US and UK have banned certain drugs, developing countries like India should take a closer look at it. We should have the red flag going and see if it is bad for Indian population as well,” suggests Dr Talat Halim, who heads the Accidents and Emergency department of Max Super Speciality Hospital in New Delhi.

Deshpande, however, argues that if a drug banned in other countries is not banned in India that might be because genetic studies done in India are backing it. The quantity of the ingredient used may also differ. “Study done outside is not relevant if I am not using the same dose,” asserts Deshpande.

Many drugs that are banned in other countries like analgin (brand name Novalgin, Baralgan), cisapride (Ciza, Syspride), phenylpropanolamine (D’Cold, Vicks Action 500) and nimesulide (Nise, Nimulid) among several others, continue to be sold OTC in India. Research shows that long term use of such medicines can affect human health in various ways like damaging liver, causing irregular heartbeats, depression, blood pressure fluctuations etc. Most European countries have banned the manufacturing and consumption of these drugs. The use of nimesulide, which is known to cause liver failure, was earlier suspended by countries like Finland, Spain and Portugal. Later, even countries like Bangladesh banned this drug for both adults and children. The European Agency for Evaluation of Medicinal Products (EMEA) has prohibited the use of the drug in children below 12 years.

The fact of the matter is that even though these drugs are globally banned due to harmful side effects, since these drugs are not banned in India, chemists and stockists do not hesitate to sell these drugs. And interestingly, instead of warning patients about the controversy that engulfs these drugs, some of these are even being displayed upfront by chemist stores. Gulhati says, “It is not only inhuman and unethical but most dangerous to dump globally banned and/or discarded drugs in India particularly on poor and illiterate patients.”

Vicious circle

Halim feels that it is a ‘vicious circle’ starting from doctors. “If doctors stop prescribing drugs that are harmful to patients’ health, chemists will automatically stop selling since there are no patients asking for it, and hence, manufacturers do not produce it. Certainly, much of the problem can be solved like that,” opines Halim. “The manufacturers have every reason to sell their products if there are buyers,” adds Dr Halim.

But why do doctors continue to prescribe banned medicines? Lack of awareness is a major reason, says Halim. “We are all programmed. Everyone is writing medicines that their teacher or senior has been writing and do not bother to cross check before prescribing to patients,” reasons Halim.

However, normally, drugs banned in India should not be manufactured or sold in the country; but unfortunately, most of the time when ban orders are issued some lacunae is left. “In such cases, manufacturers either get stay order from court or manage to avoid the ban order by making minor, insignificant changes in the product,” says Gulhati. For instance, combination of metoclopramide with other molecules, except aspirin and paracetamol, was banned several years ago. But due to defective wording of the order, a combination formulation containing metoclopramide and simethicone is openly being sold, says Gulhati.

According to Deshpande, banned drugs are not available in the market; rather it is just a common perception. He argues that some of the combination drugs are not approved by the DCGI, but that does not mean that these drugs are banned. Such drugs are available in the market because they have received grant from the state drug controller, but the common perception is that they are banned and yet available.

Remarkably, recently there is a good amount of literature listing these banned drugs. Private players like MIMS, Current Index of Medical Specialities (CIMS) and Indian Drug Review (IDR) bring out such reviews. “These organisations use a few starting pages of their journal or review to list some unnecessary combinations and dangerous warning against their use,” adds Halim. Doctors are also often affected by huge advertisements of these medicines running across the country. “The pharmacos in India market their drugs and products heavily and it is not just marketing but more than that. In India pharmacos are incentivising doctors and chemists to motivate them to prescribe drugs manufactured by them,” avers Halim.

However, Gulhati feels that there are also vested commercial interests which exert enough pressure on DCGI to ensure that medicines with vulgar profits are not banned.

Generic name Use Reason for ban Brand names (Company)
1. Analgin Pain-killer Bone-marrow depression Novalgin , Baralgan (Aventis)
2. Nimesulide Pain-killer, fever Liver damage Nise (Dr. Reddy’s), Nimulid (Panacea)
3. Phenylpropanolamine Cold Brain haemorrhage D’Cold, Vicks Action 500
4. Cisapride Reflux, constipation Irregular heart beat Ciza (Intas)
5. Droperidol Anti-depressant Irregular heart beat Droperol (Troikka)
6. Furazolidone Anti-diarrhoeal Cancer Furoxone (Glaxo), Lomofen* (RPG)
7. Nitrofurazone Anti-bacterial Cancer Furacin (Glaxo), Emfurazone (Emcure)
8. Piperazine Anti-worms Nerve damage Helmazan* (Noel)
9. Quiniodochlor Anti-diarrhoeal Damage to sight Enteroquinol (East India)
10. Tegaserod Ulcerative colitis Heart attacks, Strokes Ibsinorm (Sun Pharma), Tagon (Intas) .
11. Thioridazine Schizophrenia Abnormal heart beats Ridazin (Sun Pharma), Thioril (Torrent
12. Human Placenta Ext. Vitiligo Infection from placenta Placentrex (Albert David)
* denotes it is a combination product. Nimesulide has just been banned in Ireland, Singapore and Nigeria.Analgin, Furazolidone and Nitrofurazone are banned for use even in animals in the United States.

Analgin is banned even in Nepal, Vietnam and Nigeria.

(Source: MIMS, April 2008)

Need of the hour

Although Halim suggests that doctors are to be targeted first for spreading awareness because they can make a difference by reaching masses, he also feels that authorities need to gear up the system. “There are drugs that are not just internationally banned but the Central Drug Standard Control Organisation (CDSCO) has also banned them, but these are still available in India and are often prescribed to patients. The drug authorities here are not very strong and vigilant,” complains Halim. While America and European Union have strong regulatory mechanisms like the US FDAs, there is no doubt that India lags in this regard. “Our FDA is not strong. Even after a drug is banned internationally, we take at least six to eight months to take a note of it,” adds Halim. Lack of ADR monitoring centres in the country also leads to little reporting of adverse reactions, resulting in some undeserving drugs managing to get a foothold in the market.

However, the government has recently taken a few positive steps to manage the problem. The establishment of a National Pharmacovigilance Commission and other planned changes in drug regulation are some such steps taken by the government. India is a vast country with multi-ethnic population. It is therefore necessary to have a viable ADR data capturing system. The Indian Central Drugs Regulatory Authority (CDRA) has therefore set up a vibrant pharmacovigilance 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 paramedical interventions. “The ADR monitoring centers, reporting mechanism and information gathering mechanisms are all there in place in the country. Every state has a separate drug inspector,’ informs Deshpande.

However, he agrees that only having a pharmacovigilance centre is not enough as most of these offices lack manpower and adequate infrastructure to mine the data. “There are problems like inadequate and poor quality manpower, infrastructure. There are also hierarchical problems and competency enhancement is completely neglected. Even DCGI’s office lacks staff and this is no secret,” emphasises Deshpande.

There seems to be no end to this vicious circle and different stakeholders will keep passing the buck. It will need concerted efforts on the part of regulatory authorities, medical professionals and pharmacos themselves, probably prodded on by healthcare activists and NGOs to sweep banned drugs into dustbins.