New Delhi: The so-called “combination drugs” will need a no-objection certificate (NOC) from the Central drug regulator before they get an approval from state drug authorities.
The latest decision comes in the wake of the furore over the drug controller general of India’s (DCGI) directive to pull 294 “irrational” combination drugs from the market because of questions about their efficacy and safety. These drugs are sold under 1,100 brands in India.
Keeping tabs: Drugs controller general of India M.Venkateswarlu.
India’s drug industry generates revenues of Rs4,000 crore annually by selling 3,000 combination brands, most of which are not approved by the controller, but have been okayed by one or more state regulators. These fixed-dose combinations combine two or more drug molecules meant to cure multiple ailments through a single medicine.
An NOC will ensure greater coordination between the Central and state drug regulators in the future and eliminate ambiguity over the drug combinations that ought to be sold in the market.
The controller has assured the industry that he would respond to such applications for a combination drug within 30 working days as eight technically qualified people have already been hired to clear applications related to combination drugs.
“The drug manufacturers will need an NOC from us before the state authorities issue licences to them. We have asked the state drug controllers not to approve any fixed-dose combination drugs unless they have been approved first by the office of the DCGI,” said M. Venkateswarlu, the drug controller. “Drug makers only need the NOC from me, the licences will still come from the state drug controllers.”
On 19 October, Mint reported that at least five state drug regulators had sent notices to the drug makers, asking them to stop manufacturing of these drugs. The existing stock in the market will also be phased out over the next couple of months.
While the industry has agreed to withdraw 150 drug combinations that have been categorized as “banned” and “absurd” in the list, they are contesting the regulator’sdecision to freeze manufacturing and phase out sale from the market of the remaining 144 drugs.
Of these 144 drugs, the DCGI has sought clinical trials, bioequivalence, stability and other safety data from the drug makers. The Economic Times reported over the weekend about the industry agreeing to withdraw some of the drug combinations.
State drug authorities are looking at each other while giving out licences, according to Venkateswarlu. “Just because some other state has approved it, this one also approves it and thus becomes a chain reaction,” he said. “If a drug has 100 brands, this means a single mistake gets multiplied by 100.”
Ram Mohan Sharma, drug controller for Haryana was part of the Chandigarh meeting where the NOC decision was made, and says that the controller had promised a quick response to queries from state authorities on whether a particular combination drug was already approved by the controller’s office.
As part of this new agreement, the DCGI also intends to strengthen the communication network with all the state drug controllers, allowing them to see and share combination drug application requests.
Meanwhile, India is proposing the formation of a Central drug authority. The Bill for setting up this authority—modelled on the lines of the US Food and Drug Administration—was introduced in Parliament during the monsoon session and is pending.