Experts emphasize on the patients’ right to complete information

The drug regulators need to be vigilant and consumers should be completely informed


New Delhi: Kartik was only 35 when he started relying on heavy doses of insulin and was struggling with blood sugar control. After a few weeks, the specialist put him on a combination of pioglitazone 7.5 mg + metformin (500 mg). And it worked miracles for him. But only until pioglitazone was banned by the government. The controversial drug was linked to bladder cancer. But when it was brought back on the shelves after evaluating and confirming that it doesn’t have any adverse effects, no public announcement was made. It left even the doctors confused as to what has been going on.

When the most common household drug names and treatments suddenly flummox the country’s drug regulators, it impacts patients in more ways than one. Take, for instance, the case of Diclofenac 1 mg acute pain injection. It was alleged that it contains Transcutol-P, which isn’t widely used in the parenteral formulation owing to its harmful effects on the kidney. On this, Dr Nitin Kimatkar, Professor, Government Medical College, Nagpur explains, “Transcutol P is specifically designed for use by the parenteral route. It is listed in the Indian Pharmacopoeia and the British and European Pharmacopoeia do not restrict the parenteral use of Transcutol P.”

People need to be informed about the correct drug safety and usability directions before such claims are made. For instance, in this case, each 1 ml Diclofenac injection contains 200ml of Transcutol P, which is well within safety limits as per Permissible daily exposure (PDE) in animal studies for intramuscular/intravenous routes that range from 434 mg/day to 784 mg/day.

The drug regulators need to be vigilant and consumers should be completely informed. We need an active advisory to inform patients why a particular drug is unsafe or recalled. The patient has the right to know all relevant information on the drugs that can replace their preferred choice.

“For a patient, who has relied on these treatments for decades, the ban is even more confusing, more so in case of bans on specific medications with a broader range under them. You ban one product in the range and the consumer often mistakes it for a flaw in the entire drug profile,” shares Dr. Darsh Goyal, Joint Replacement surgeon, Bhagat Chandra Hospital, Delhi

Experts also highlight the need for a framework to generate data related to adverse drug reactions. And before a drug is banned, there is a need to tell the patients about what to use in its place. Suspending a commonly used drug can put patients at the receiving end. The consumer eventually doesn’t know what to believe. Ideally, the drug should be allowed to hit markets only after undergoing stringent data led evaluation/ approval. And once the decision has been taken, the patients have the right to know every side of the story instead of just one aspect that makes headlines.