Chronicle Pharmabiz editorial, "FDC Mess" appeared on August 11, 2010 at www.pharmabiz.com is an important topic for the Indian pharmaceutical industry and needs to be debated by all the erudite community and usher in a change in the regulatory system and medical practices as well. The topic becomes more relevant to carry forward in the wake of the new threat in the form of the most notorious 'Superbug', which has been named NDM-1. It's beyond our scope to debate for and against the origin of the 'Superbug.' But it can be said with certainty that the overall practice in the disease management in India needs thorough introspection, intervention and improvements.
It's agreed that the pharmaceutical companies do not run a charity and obviously focus on profits. But is it not important to have equal focus on the 'Social Objectives?' And therefore, follow the 'ethos' and 'ethics?' It's well known that the regulatory system is already in place. Any company desirous of launching new product(s) must comply with the provisions in the Schedule-Y, with no exceptions; no matter however trivial the change in the new product as compared to the original product(s) - be it fixed dose combinations or NDDS. But in several instances, several companies manage to draw analogy, make extrapolations and provide a convincing rationale to the drug authorities. But why do the drug authorities need to deviate from the laws that they only have created? This is not as simple as a traffic constable 'letting' the traffic violator for whatever reasons! One must appreciate that medicines are serious business and must be taken seriously by all concerned.
In one of the important seminars, the same former DCGI, Dr. M. Venkateshawarlu (who is in the centre of this topic), was asked by one of the participants, "Sir, as you know FDC of Clavulanic acid with Amoxicillin had undergone extensive trials for Toxicology and Pharmacology. But can you tell all of us here, whether any such trials have been done in India for FDC of Clavulanic acid with Cephalosporins, before approving drug license, while you were holding the office?" Genuine question, but answer was evaded. Interestingly, not many such preparations are sold anywhere else in the world, though several clinical trials are underway.
Resistance to Carbapenems: let's take one important example - as per the leading drug index, 'CIMS' there are as many as 72 brands of Meropenem, one of the Carbapenem derivatives; besides, there 'N' number of generic alternatives as well.
The vital question is, should the drug authorities permit licence for so many brands, knowing very well that the companies will make aggressive push for higher sales?
Other questions
● Is there a warning in the label that the product must be used only in resistant cases, based on sensitivity testing?
● Do the drug inspectors check whether the products are sold in small nursing homes and retail outlets, indiscriminately?
● Is there a penalty clause for the doctors who misuse the product, i.e., in a non-resistant case, just because they are obligated to company that took them for a cruise to overseas trip?
● Do we need cheaper alternatives or judicious use of such high-end antibiotics?
● Do the consumers know that they are subject to clinical trials and treated like guinea pigs in most of the cases?
There are many more questions that will only remain unanswered as long as the neutral people remain mute spectators without acting in the public interest. While it's absolutely essential that System must be spruced up, it also is essential to increase the public awareness regarding misuse of certain drugs and the fact that they are being taken for granted. We hardly find any activity in Medico-legal cases. Does it mean that the Indian Doctors commit negligible mistakes as compared to their western counterparts? The difference is in the 'Public Awareness' and Consumer exercising the Right.
How many Indians know the Constitutional Rights, at least in this regard? In a country where Doctors are considered as 'demi-Gods,' this is perhaps a far-cry. But somewhere the beginning has to be made. It's a well established fact that no initiative is worth it without the public participation.
Why the public must be at the receiving end when the entire pharmaceutical industry and healthcare industry thrive on them? Why is that the "Consumerism" is not strong in this regard?
It's not justifiable to argue in favor of the pharmaceutical companies on account of the huge business loss they may incur. Take the case of 'Rofecoxib (Vioxx)' or 'Nimesulide.' Brands worth billions of dollars were asked to be withdrawn. What's more! Patients' kith and kin were compensated for the fallacy of the drug companies. While in India, Nimesulide is still sold like a hot cake despite the ban… now it's said that only pediatric dosage form has been banned.
The most important central message should be bringing accountability of all the key people involved in disease management and increasing the public awareness.
Otherwise, even selling of expired drugs can become legitimate and people may argue in favor of the pharmaceutical companies, on account of losing their crores of business!
Let's not forget that the USA is what it's today, "The Superpower,' mainly because of the solid implementation of Social Justice. Let us not make India a Superpower of 'Criminal' Justice or Justice that's a criminal waste!
(The author is Inventor & Trainer, he has more than 19 product patent applications; some are granted).