The healthcare system in India is delivered not only by allopathic doctors and hospitals but also ayurvedic practitioners and holy healers. These two extreme divisions in the healthcare sector makes any implementation of policy in the country difficult. The Indian healthcare system is already facing many challenges in trying to serve its 1.3 billion population. The rise in the usage of banned drugs is intensifying the challenges.
India has become a dumping ground for banned drugs. The problem is, few people know about the banned drugs and consume them unawares, causing much damage to themselves. Banned drugs may give immediate relief to our body, but in the long term they affect the performance of our vital organs. The issue is severe, and we must not delay in spreading the warning to both the offenders and the innocent consumers.
In 2016, 344 fixed dose combination (FDC) drugs were put under the banned list. Some common names are Novalgin, Vicks500, Nimesulide, etc. Currently, in the market, 3,000 different brands are marketing the same 515 molecules of medicines. It doesn’t astonish anyone that many of these brands are banned FDC drugs.
India lacks robust regulatory policies that can keep a check not on just the quality of the drugs, but also the molecule or FDC. The side-effects of banned drugs are not seen immediately, but over a period.
The prevailing regulatory policies aren’t implemented and are encumbered by several hitches. Inadequate manpower is one of the biggest issues faced by the regulatory authorities. With 3,000 brands in the market, there aren’t enough personnel to inspect the quality of the medicines produced.
Unfortunately, even if manpower increases, there remains the problem of ill-equipped infrastructure, including testing laboratories. Most information on banned drugs and reasons for the ban are sought from other countries. Another major issue in relation is that the authorities themselves lack accurate information and database on drugs that are banned but which still exist in the market. They need to fix these deficiencies with the help of technology and prevent such drugs from being manufactured.
The developed countries are doing their bit in quality testing and research on the effects of drugs and are restricting production of certain drugs. Sadly, many such drugs that are banned in developed countries are still manufactured in India and sold to the masses, endangering their future. India is also one of the largest exporters of banned drugs.
Another major hurdle is the lack of transparency in the bureaucratic functioning of the regulatory department and the attendant lack of accountability. This makes banning a drug a highly complicated and long legal affair. The lack of accountability is quite clearly seen in the lack of implementation of policies to curb the manufacturing and sale of banned drugs.
Doctors and pharmacists
Unfortunately, many banned drugs are extremely popular and easily marketed, compared to a new drug. Pharmaceutical companies prefer to manufacture banned drugs as they don’t need much marketing and consumers are aware of the immediate relief they afford. Pharmacists often substitute new drugs with the banned drugs, since they are readily available.
There is a gap in communication between the Drug Controller-General of India and drug controllers, leaving a gap in disseminating information. The snowballing effect is that many doctors are unaware of these drugs being banned and prescribe them to patients unknowingly.
Patients, too, often self-prescribe drugs when it comes to common ailments such as headaches, cold, fever or even a backache. Due to such self-prescription, allergies and anaphylactic reactions are high on the rise.
With the Medical Council of India and the DCGI becoming more vigilant on banned drugs, there will hopefully be an improvement in the implementation of the ban on these drugs. There are many policies that are yet to be announced to change the current regulatory environment for good. The Central Drugs Standard Control Organisation run by the Government of India has to develop strict guidelines regarding the list of drugs banned by the European Union and the US. Awareness programmes should be conducted in government hospitals as well as for private medical practitioners to make them aware of the status of drugs in the market.
Medical students should be taught about drugs banned from use and drugs surrounded by various controversies, so that they can refrain from using the same for patient care. Physicians should begin reporting adverse drug reactions (ADR) to the nearest Pharmacovigilance centre to help generate an ADR database.
It is imperative that the government implements the law as well as creates awareness amongst the masses about such changes. The health of the nation is one of the key indicators of the development of a country. Citizens must be aware of the harmful side-effects that drugs could have on their body in the long run.
(The writer is Director, IIHMR, Bengaluru)
