The health ministry's efforts to revoke the suspension of the diabetes drug pioglitazone has now caused complete commotion in the pharma industry. This has reduced sales of pioglitazone in key markets of Mumbai, parts of Maharashtra, Orissa and Andhra Pradesh.
The companies have gone on to misinterpret the recommendations of the Drugs Technical Advisory Board (DTAB) asking to mention on the package insert and promotional literature of the drug that it should not be used as first line of therapy for diabetes.
Further, DTAB has also mandated the cautionary advice to healthcare professionals not to prescribe it to cancer and elderly patients besides review the safety and efficacy of pioglitazone after three to six months as a ‘box warning in bold red letter’. This has confused the pharma industry and its associations to misunderstand the whole recommendation.
The pharma companies and pharmacy outlets in India are now at the receiving end. Further revoking of the suspended pioglitazone has now led to misreading for pharma companies about the package insert and box warning.
For diabetologists and general practitioners there is apprehension and lack of confidence on prescribing the drug. The Union government has caused more chaos than concern to the 60 million diabetic patients, said experts.
They have pointed out that the packaging inserts under drugs laws globally and in India under Drugs and Cosmetic (D&C) Act indicated that the manufactures have to mention in the insert about the warning of pioglitazone prescription with an outline. The warning should not be printed on the box.
But the recommendation of the DTAB is now totally misunderstood, and the industry and its associations are taking law into their own hands and confusing themselves. All that they need is to approach DTAB.
“It was the DTAB onus to educate the pharma industry through state drugs control departments who could provide the advice through a one-hour workshop,” said experts.
The future of the pioglitazone prescription is now to be seen. While medical experts are convinced on its safety, yet there is fear among the educated patient population who are requesting for a change of drug.