Events & Issues

New Delhi, 29 November 2010

Antibiotic Policy

CHECK DRUG OVER-USE

By Dhurjati Mukherjee

It is well known that multi-national companies (MNCs) have been continuously pumping money into research and development for newer and sophisticated drugs. Chronic diseases such as diabetes and cardio-vascular ailments require research and developing new drugs are indeed lucrative for MNCs. However, drug discovery is itself risky and fraught with many failures as some molecules may falter on account of safety or efficiency at the final stages.

Meanwhile, the widespread use of antibiotics, even for minor infections, has resulted in resistance to some of these drugs. In fact, the overuse of antibiotics has become a problem whereby doctors opine that there is need for restriction in prescribing antibiotics as indiscriminate use could lead to the microbes becoming resistant to drugs. Also, with most drugs being costly many people belonging to the economically weaker and poor sections are not in a position to purchase these when diseases affect the family.

In view of this, the Government’s decision to come out with a National Antibiotic Policy, expected to be finalized this month, is welcome.  Recall, a 13-member expert panel was constituted in September to lay down the policy and ways to implement the same. Specially, as many developed countries like Sweden and UK already have such a policy. In India, Tamil Nadu recently framed an antibiotics policy.  

Accordingly, a task force would be constituted in each State to develop and implement strategies in both the public and private sector. NGOs too would be involved as they provide health care at a minimum cost to the poorer segments of society at the grass-root level who are generally afflicted with various types of diseases and suffer the most.

Another component of the policy is that drugs and therapeutic committees along-with hospital infection committees would be set-up. As also a national reference microbiology laboratory with a network of accredited diagnostic labs all over the country.

Further, antibiotics would be classified into three categories --- non-restricted, restricted and very restricted. There would be a selected list of antibiotics which cannot be sold without a doctor’s formal prescription. According to Health Ministry sources, stringent penalties would be imposed if this norm is violated. Antibiotics not on the essential drugs list should not be procured, prescribed or made available.  

The policy will also make it mandatory to test the presence of antibiotics in food items. Many times it has been found that antibiotics are introduced in chicken feeds to make the birds plump. With this new policy, poultry too would get tested. And the policy would be included in the MBBS syllabus alongside the use and misuse of antibiotics. Moreover, in continuing Medical Education Programmes (essential for re-registration of doctors), rational use of medicines and antibiotics would be made mandatory.

Significantly, the importance of drug regulation is vital given that diseases are increases and with it many types of complications. Clearly, the policy would be of great help to the people in addition to doctors who would educate themselves about what to prescribe and the correct dose thereof.

Sadly, despite a World Health Organization (WHO) guideline, directing doctors not to recommend more than five drugs in a prescription, this has not being followed in several cases. On the obverse, it has been found that doctors often prescribe antibiotics instead of paracetamol to treat simple ailments like cold.       

Meanwhile, in spite of efforts by the Central Drugs Standards Control Organization (CDSCO), the apex drug regulating agency in India, many banned drugs are still sold all over the country. Not only that. Shockingly, medicines discarded by regulators elsewhere, because the risks are more than the benefits, remain approved for manufacture in India. Undoubtedly, a cause for concern.      

Some examples. The anti-diabetes drug, Rosiglitazone, was banned by the European Medicines Agency in September amid concerns that it increases the risk of heart attacks. The US drug regulators too ruled that Rosiglitazone should be a ‘last choice’ drug when no other drug worked. In fact, Nimulid suspension, (a pediatric formulation to treat fever and pain) Solvin Cold (a decongestant for colds) and Tegibs (to treat irritable bowel syndrome and constipation) are among the drugs which are banned in most parts of the world but available in India.        

Though CDSCO has set up a pharmaco-vigilance network of 26 centres to monitor the adverse effect of drugs, these have been ineffective. Many see CDSCO’s action as delayed and non-transparent. For instance, the anti-diabetic drug Phenformin, discarded by most countries world-wide in 1971 was withdrawn in India only in 2003, that too after lawyers drew the court’s attention to its continued sale.        

Thus, it is imperative that drug regulation is enforced all over the country. And periodic review of drugs undertaken whereby those found unsuitable should be banned. This apart, the vital question before the Government is ensuring low-cost medicines to BPL and economically weaker sections.

Arguably, how does one ensure supply of necessary medicines to this section as the rural health centres and the sub-divisional hospitals are rift with corruption?  Plainly, strict punishment has to be enforced if the country’s disease burden has to be brought down. This is possible only through proper health care and availability of correct medicines at the right time. 

There is no gainsaying, that drug regulation and ensuring cheap drugs to the distressed sections is an uphill task. However, whatever may be the challenges, this needs to be done. The time has come for the Central and State Governments to enlist the services of voluntary organizations who are best equipped to carry out the task of treating and providing medicines to the poor effectively in the rural and semi-urban areas. ----- INFA

(Copyright, India News and Feature Alliance)