सत्यमेव जयते – Generics Drugs in Rajasthan

The recent episode in ‘’सत्यमेव जयते by Aamir Khan has raised a mini-storm – the protests by the doctors belonging to IMA, the pharma companies and even reactions from the common man. The intentions of Dr. Samit Sharma appear to be noble.  Dr. Samit Sharma is medical doctor turned administrator (He is MD in pediatrics, i.e. a specialist in disease of children). The point he wants to drive home is that the poor in Rajasthan should get medicines at low prices, via the generic route.

Here in this blog, I am detailing to the non-pharma, non-medical populace, what exactly are generic medicines.

Introduction:

What is a generic medicine?  For instance, Crocin or Metacin contain paracetamol 500 mg. Crocin / Metacin are the brand names while paracetamol is the chemical or generic name.

So any product sold as “Paracetamol Tablets”, but without a brand name, becomes a generic medicine.

Most of the modern products originate from USA, Europe or Japan. When a product of original research is first marketed, it is patented. It is estimated that on an average a new product right from research stage to the marketable stage may take anywhere between eight to 12 years or even more.  According to PhRMA, the U.S. pharmaceutical industry’s advocacy group, it costs US $1.3 billion (in 2005 dollars) to bring a new drug to market, which also factors in the rate of failure. The patent may last for several years seven or more.  Once the patent expires, any company can market that product (of course they have to undergo rigorous process for that) and are called generics.

India before 2008:

What happened in India till the patent laws were strictly enforced in 2008? Our leading Indian companies like Torrent, Cipla, Ranbaxy, Sun Pharma etc. found a loop hole in the then existing patent laws and developed a process called ‘reverse engineering’. The patent laws in those days were for the ‘process of manufacturing’ and not the end product.  These companies, almost overnight, were able to synthesize the new product and market them in India, through a different manufacturing process, which was not patented. Nevertheless, very important, in terms of quality and efficacy it matched the original research product in all aspects, including bioequivalence. They were dubbed as ‘copycat’ products by the originators but were available to the Indian patients at costs almost 10% (not a typo error) of the original brand. And that is why the US-FDA and the US based big-pharma started fearing and even hating the Indian companies.

Dubbed by the US Big Pharma as ‘copycats’ ‘branded generics’ did well to serve the Indian patients till 2008, when the patent laws became more stringent.

By the definition of USA Big-Pharma, the leading Indian brands like Cifran (Ranbaxy), Domstal (Torrent) or Nexito (Sun Pharma) are branded generics. When these brands and the drug became very popular, the SMEs in India started selling ‘generics’.

These ‘generics’ are never promoted to doctors but only to retailers, not only at very low costs but also by offering ‘lucrative bonus offers’ (sometimes even five strips free on the purchase of  one strip – again, no typo). Their only strategy was to induce the retailers to substitute the prescriptions of doctors with these ‘cheap’ brands.

And here is the catch! If stringent quality standards are to be maintained how is it possible for such companies to offer products at throw-away prices?

In the pharma industry, quality is a function of many factors – from quality of active pharmaceutical ingredients called API. It is not just assay but also the impurity profile, shelf life (remaining period) of the API when used for taking a batch, the specifications and attitude of the management, not when a batch passes out but when it fails, as recirculation for production adds to the cost. A batch has to pass the tests even at expiry!

Then there are inventory carrying costs. These all need to be considered when a price is fixed.

This is where companies of repute and those with focus on quality get differentiated from others. Bio-equivalence tests done by these companies are very costly. The SMEs may neither have the resources nor the attitude, as this would certainly add to the costs. Therefore, for companies who maintain high standards of manufacturing and quality, it is not possible to give products at such throw-away prices, as is currently happening in Rajasthan today.

I am on the verge of writing a letter to Dr. Samit Sharma IAS, whose brainchild this is, requesting him to conduct bioequivalence tests of generic products sold in the generic shops with those of companies of repute in some good and renowned laboratories like Lotus Labs.

The biggest flaw in Dr. Samit Sharma’s plan is that now retail chemists will dominate the market – whoever offers the highest profit margins to the retailers, wins. and the retail chemists are hardly bothered about quality – only profits.

Lets hope that all genuinely keep the health of the poor in mind.

सत्यमेव जयते

 

 

 

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4 responses to this post.

  1. Interesting read about generic medicines. Are these generic medicines available only in Rajasthan or in Mumbai also?

    Reply

    • In Rajasthan, it is mandatory for doctors attached to government hospitals to prescribe generics. There is however one flaw – the credibility and the integrity of the suppliers.

      The Society for Medicines at Affordable Costs for all endeavors that the Rajasthan model should be replicated in other states too, but with a difference.

      The quality of the generics supplied should be subjected to rigid quality control measures. The humble dabbawala in Mumbai, the rickshaw-puller in Jodhpur, a Ratan Tata or a Mukesh Ambani should get the same quality of medicines.

      Reply

  2. Thanks for the very useful information! One can now be mindful before just rushing in to hunt for ‘generic drugs’ just because they are more affordable. One is also under the impression that the Indian Pharmaceutical industry is price controlled through the DPCO. Is this regulatory body defunct? Or are the masses indeed benefitting from the price control measures they stipulate? Could you throw some light on this aspect also as this is a related subject but not discussed in SMJ Episode 4? Thanks again!

    Reply

    • Hello Gopinath,

      GOI has set up a body called NPPA (National Pharmaceutical Pricing Authority) to implement and enforce the provisions of the Drugs (Prices Control) Order. Not all products are under DPCO, only the essential and life-saving. saving drugs. So far only around 72 products are under DPCO.

      Reply

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