New Delhi: India’s drug quality regulator has started discussions with makers of so-called combination drugs to reach an out-of-court settlement over a ban, which is currently being contested in several courts.
The total annual sales of the combination drugs segment is around Rs4,000 crore.
Several Indian drug firms manufacture combination drugs, which do not have Central regulatory approval. The drugs controller general of India, or DCGI, ordered that 294 such drugs be taken off retail shelves and hospital dispensaries.
The proposed settlement—of cases being fought before the Madras high court and other courts—involves companies voluntarily withdrawing some of these drugs from the market and the regulator allowing the rest to be sold under increased post-marketing surveillance.
“We are in talks with the industry associations and trying to work out an amicable solution,” said the regulator, Surinder Singh. “The broad outline is to allow some drugs to be marketed while keeping them under pharmacovigilance. The others should be voluntarily withdrawn by the manufacturers.”
A solution was expected by July, added Singh, who assumed office in February when the industry and regulator were already deeply divided over the issue.
No instant relief: The drugs controller general of India has ordered 294 combo drugs be taken off retail shelves, a decision that manufacturers have contested in courts. The regulator expects a solution by July. (Rajeev Dabral / Mint)
While there is no clarity right away on the number of combination drugs that will be put in each category, Singh indicated that roughly one-third of the 294 drugs will be withdrawn by the drug makers. Talks are under way to decide the status on the remaining two-thirds.
These 294 combination drugs—created by mixing two or more drug molecules that cure different ailments independently—are sold under 1,100 brands in India.
Pharmacovigilance is the process of collecting, monitoring and evaluating information from health care providers and patients on the adverse effects of medications, typically after a drug has been introduced in the market.
An executive of the Confederation of Indian Pharmaceutical Industry (Cipi), a lobby of small Indian drug makers, confirmed they were in “negotiations with DCGI to come to a formula” that could settle the litigation out of court.
Most of these drugs are manufactured with the approval of state drug controllers who are not responsible for drug quality and efficacy.
Industry experts cautiously welcomed the development, but questioned the ability of the poorly staffed DCGI office to constantly monitor the effects of these drugs when they are sold in the market.
“It is a workable solution if the data collected through pharmacovigilance is actually concurrently analysed. It should not remain a data collection exercise,” said Prafull D. Sheth, vice-president of policy think tank International Pharmaceutical Federation.
India has 24 peripheral pharmacovigilance centres, five regional centres and two zonal centres. The office of DCGI is where the information is to be pooled but, so far, no concrete drug alerts, warnings or recalls have come out of this system.
The Indian regulator continues to depend on red flags by global counterparts, especially the US Food and Drug Administration, to then investigate a drug in India.
“How can there be a compromise in case of a violation? These drugs haven’t yet come clean on the safety and efficacy parameters,” noted one pharmaceutical expert, who didn’t want to be identified.
Daara Patel, secretary general of the Indian Drug Manufacturers’ Association (Idma), which represents small and medium medicine makers, said the industry body had told DCGI that the drugs were being marketed for the last two years and had not thrown up any adverse reaction data. Patel added that Idma was asking its members to either give scientific evidence detailing the effect of these drugs, especially irrational combinations, or withdraw them.
Cipi had filed a public interest litigation in the Madras high court in November against an order by former DCGI M. Venkateswarlu, who directed drug firms to take these drugs off shelves until their efficacy and safety was proved clinically.
The order was granted a stay by the court.
To guard against similar problems in future, Singh said any new drug combination— treated as a new medicine under the Drugs and Cosmetics Act, 1940—will need a “no objection certificate” from DCGI before it gets an approval from state drug controllers.
This will ensure greater coordination between the Central and state drug regulators in the future as well as eliminate confusion over such drugs in the market.