Doctors' dilemma: To Prescribe or not to Prescribe

by Priyanka Pulla

Glaring contradictions between the US FDA's stance and the Indian regulator's rules on drug safety norms have doctors and patients flummoxed

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Doctors' dilemma: To Prescribe or not to Prescribe

Image: Getty Images

A research and development centre at Ranbaxy Laboratories in Gurgaon

Anantharaman, an endocrinologist at Bangalore’s Apollo Hospitals, has been wary of prescribing Indian biological drugs ever since he learnt about the quality problems surrounding some of them. He often prescribes recombinant human insulin—insulin that bacteria produce when the human insulin gene is introduced inside them. This diabetes drug is prepared by a complex method, and minor manufacturing defects can make a big difference to its efficacy.

This is why, when the US Food and Drug Administration (FDA) banned three facilities of the Mumbai-based Wockhardt Limited—the firm that manufactures the Indian version of this drug—from exporting to the United States because of major lapses in quality control, Anantharaman switched to foreign brands.

While Wockhardt reported a drop of 78 percent in its profit for the March quarter because of the ban, it continues to sell its products in India. And though there is no government edict preventing the drug from being sold in India, Anantharaman is not taking any chances.

The endocrinologist isn’t alone in his concerns about the quality of Indian drugs. Many doctors, citing absence of rigour on the part of the Indian drug regulatory body, Central Drugs Standard Control Organization (CDSCO), are being cautious just like him. A case in point is the varied reaction to Ranbaxy, which was engulfed in regulatory problems last year when four of its plants were banned from exporting to the US.

Several doctors and major hospitals such as Jaslok in Mumbai have misgivings about Ranbaxy’s products. Jaslok Hospital has a policy against Ranbaxy drugs.

“We are not using them, except a few drugs, where we have no substitutes. When there is speculation over the quality of a drug anywhere in the world, unless we are hundred percent convinced otherwise, we have to take some steps,” says Tarang Gianchandani, the CEO of Jaslok Hospitals.

On the other hand, other hospitals such as Apollo and Medanta eventually decided to continue prescribing the drugs. When asked if he was worried about the quality of Ranbaxy drugs, Naresh Trehan, chairman of Gurgaon-based Medanta, said the hospital’s quality-control lab routinely tested the drugs instead of relying on the Indian drug regulator’s or Ranbaxy’s statements alone. Apollo Hospitals’ joint managing director Suneeta Reddy turned down a request for an interview.

Such concerns reflect the dilemma that the medical community in India faces when prescribing drugs from tainted Indian pharmaceutical firms. These firms were found guilty of manipulating drug quality control documents, which means the safety and efficacy of their drugs is suspect. When Sun Pharmaceuticals acquired Ranbaxy in a $4 billion deal in April this year, investors were hopeful that Sun would be able to fix Ranbaxy’s quality issues.

But in May, Sun Pharmaceuticals’ own regulatory problems got worse, with the US FDA saying the drug maker had not adequately addressed previously listed shortcomings at its Karkhadi plant.

The FDA said it would strengthen its scrutiny of Sun’s operations. A spokesperson from Sun told Forbes India that the firm would be responding in detail to the FDA and would strengthen its quality controls.

But even as the FDA increases the spotlight on Indian firms, CDSCO has maintained that the drugs from these companies are above board. In mid-2013, CDSCO carried out its own tests on Ranbaxy’s medicines, but found no quality issues. It is this glaring contradiction between the FDA’s stance and the Indian drug regulator’s stance that has doctors and patients flummoxed.

When asked if he was dissatisfied with the Indian regulator’s lack of action against Ranbaxy, Medanta’s Trehan said, “What choice do I have? We can’t start importing expensive drugs from the US.”

Lack of manpower and lax rules
The main reason for this contradiction on drug safety is that CDSCO’s net is much smaller. Its ambitious plans to recruit new personnel and create new positions have mostly remained on paper, and CDSCO continues to be dramatically short-staffed with a mere 1,500 inspectors for over 10,000 manufacturing plants. State regulators are no less crippled. Karnataka, for instance, has only 49 drug inspectors overseeing 28,000 medical stores and 248 drug manufacturing units.

The Indian regulator could be missing many quality control issues simply because it doesn’t have the staff to conduct a thorough investigation. With 1,500 inspectors, it’s impossible to monitor a large enough sample of drugs on sale.