New Delhi/Mumbai: The Drugs Controller General of India (DCGI), the regulator responsible for pharmaceutical quality, has resorted to a sparingly used provision in the law governing the sector to ensure a recent order halting manufacturing of 294 so-called combination drugs, which have not been tested in their blended forms, is implemented by state drug controllers.
On Wednesday, the office of the DCGI issued a directive under Section 33(p) of the Drugs & Cosmetics Act, 1940, to its counterparts in states to terminate the licences granted by them for manufacturing and marketing of these combination drugs.
The crucial provision empowers the “Central government to make rules” that all state administrations have to mandatorily follow.
The order has made the consensus decision on banning combination drugs taken at a recent meeting of central and state regulators at Chandigarh end-October “binding” rather than advisory, said DCGI M. Venkateswarlu.
These 294 drugs in question are sold under 1,100 brands by hundreds of drug makers—big and small—and generate about Rs3,000 crore in annual revenues for drug companies.
The DCGI’s communication came a day after the Madras high court granted a stay on the regulator’s earlier order calling for a withdrawal of combination drugs from the market on Tuesday.
The court order, reported first by The Economic Times on Thursday, followed a petition filed by Confederation of Indian Pharmaceutical Industry (Cipi), a lobby of 23 state drug associations and 3,000 small drug makers, that claimed a 40% market share for these combination medicines.
On Thursday, Cipi claimed the matter was subjudice but added it will challenge the DCGI’s new order as well.
Meanwhile, confusion reigned in the industry on whether the court’s order applies only to drug firms in Tamil Nadu or across India.
The DCGI is preparing to file a writ in the Madras high court to get the “stay vacated on the ground that there is merit in the regulator’s action, which is to ensure the safety of drugs circulated in the market.”
Venkateswarlu said on Thursday that he hadn’t read the final court order but will also challenge it in the Supreme Court if the order covers all of India. “There is no clarity on the Madras high court stay whether it stays the central instruction or states’ execution,” he claimed.
Cipi chairman T.S. Jaishankar claims that the court stay is indeed applicable to the body’s 3,000 members across the country. “We are not resorting to a permanent stay on the government’s regularization process for drug approvals. We are just asking for some time that the industry needs to comply with it,” he said, adding most of the association’s members had applied to the controller seeking fresh licences for the combination drugs.
Daara Patel, secretary general of Indian Drug Manufacturer’s Association (Idma), which represents small- and medium-sized drug makers, is of the view that the DCGI’s initial order on the 294 combination drugs across the country stands suspended.
Commissioner of Maharashtra’s Food and Drug Administration (FDA), S.A. Momin, has already initiated action following the DCGI’s alert in September. Maharashtra has 580 combination drug licences held by 35 companies. “Our seven zonal offices have been instructed to force the manufacturers to stop producing these drugs, and they are also in the process of ensuring withdrawing these products from the market,” he said, adding that he will also review the court order.
Gujarat’s FDA commissioner Subodh P. Adeshara is more categorical.
“We have issued notices to all the 370 manufacturers who hold around 1,800 licences for combination drugs in the state. Since the Madras high court stay has not stopped me (from) taking action against any of these manufacturers, we are going ahead with the action,” he said. “Since the court stay always cover specific products or companies or may be members of an association, I don’t think it applies to the industry as a whole,” he added.