Till the year 2001, the drugs available to treat chronic myeloid leukemia (CML) — a common cancer of white blood cells — weren’t satisfactory. The only treatment which provided a long-term respite was bone marrow transplant. This was not only an expensive procedure, but also complex — largely because not many centres were carrying it out at that juncture.

Then, around 2003, Glivec (scientific name — Imatinib) came into the market and revolutionised the treatment of the disease. One pill a day could control leukemia. Therefore, physicians like me will agree that patients who have been on this drug ever since continue to lead a comfortable life.

However, due to its cost, the drug was beyond the reach of many. The cost is justified scientifically, but from a patient’s perspective, it is not fair. So, after the drug went off-patent, it was manufactured by dozens of Indian pharmaceutical companies. Today, a pack of 10 costs around ₹3,000. A condition such as CML was frustrating when it came to treatment, but everything changed with the arrival of Glivec. Currently, branded generics are helping to bring down the cost, apart from increasing accessibility without compromising on quality. It is a solution for an economy like ours, which doesn’t follow strict regulations on quality.

Quality issues

Despite the affordability, unbranded generics cannot provide quality assurance. While the government has instructed that only salt names of drugs be used on prescriptions, a point of concern is: Is India ready for such a change?

As a doctor, I am at crossroads while treating patients. Do I prescribe a medicine which gives quality assurance, or go for one that is more affordable but of lower quality? What is more perturbing is that this dilemma is not restricted to the treatment of CML.

It is easier for branded generics to maintain quality as they follow regulations. Take the case of Iressa (salt name, Gefitinib), a drug used for treating lung cancer. Once the branded generics of this drug became available, patients were able to access it at a cheaper rate. Consequently, patients have been able to consume one pill a day, which does the job and, thereby, avoid complex chemotherapy procedures.

 

Cancer is fast becoming a disease where a patient is dependent on medicines for an extended period of time. This makes the disease even more burdensome.

Moreover, when you approach a pharmacist for a drug with a salt name, how can he/she assure the quality of the medicine? The doctor prescribes a medicine and the dosage assuming a certain level of efficacy, but what if the generic fails to deliver on quality? This can lead to extreme unwarranted consequences.

At present, I don’t think it is possible to put generics and branded generics in the same bracket, especially when there is an increased sense of safeguarding lives of patients. I believe branded generics is the best approach to achieve universal healthcare.

Blatantly promoting generics will boomerang sooner or later, if issues around quality of such drugs are not attended. It is time we bring back ‘care’ into health, by ensuring quality, accessibility, availability and affordability.

Also, the idea behind prescribing salt names is to reach out to a larger section of the population. However, without any assurance on quality, such initiatives will be futile. The regulatory system for quality checks should be extremely robust wherein not just doctors, but even the patients and pharmacists feel confident in using any medicine under a salt name.

Going forward, there should be stringent parameters to allow manufacturers to market medicines and it must be ensured that these are adhered to.

A system should be put in place where any violation should lead to cancellation of licences or other such other stringent penalties.

Therefore, the onus to fulfil the vision of quality in healthcare delivery is not only on the doctors but also on the government, drug manufacturers, hospitals and better-informed patients who would not settle for substandard quality.

This is doable, not impossible.

The writer is Chairman, Medical and Haemato Oncology, Cancer Institute Medanta – The Medicity.

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