Mumbai: The Confederation of Indian Pharmaceutical Industry, or Cipi, a trade body of small- and medium-sized pharmaceutical firms, fought the government’s latest regulatory fiat to withdraw so-called combination drugs from the market on Tuesday by filing a revised petition and receiving a stay order from the Madras high court.
This stay order will be applicable in five southern states of Tamil Nadu, Karnataka, Kerala, Andhra Pradesh and Puducherry.
On 30 November, the Drug Controller General of India, or DCGI, the country’s regulator in charge of pharmaceutical quality, issued a special order making it mandatory for state drug controllers to withdraw manufacturing licences for all combination drugs issued in their respective states.
This order—under Section 33(p) of the Drugs & Cosmetics Act, 1940—was invoked after the DCGI’s first letter in October to states asking them to take appropriate action to cancel state licences for combination drugs as they were not issued as perCentral norms.
The court’s latest order came even as the Central Drugs Standard Control Organization, or CDSCO, the DCGI’s administrative department, filed caveats in high courts in Himachal Pradesh, Punjab, Haryana and Uttarakhand to pre-empt stay appeals by bodies such as Cipi on Monday and Tuesday.
Cipi received its first stay order on 27 November against the DCGI’s October directive. CDSCO, which will file caveats in other states such as Maharashtra, Gujarat, Andhra Pradesh, Goa and a few others shortly, will also file a counter-affidavit on Wednesday in the Madras high court to get the stay vacated, said M. Venkateswarlu, DCGI.
Though Cipi had claimed that the first stay order was applicable across the country, the DCGI said: “Since the Madras High court stay was based on a petition filed against the Tamil Nadu drug controller’s action following the Central order, it would not stall the action of other states.”
Drug controller M. Venkateswarlu says his department may even appeal to the Supreme Court to ensure that mandatory withdrawal of licences for all combination drugs is implemented
Daara Patel, secretary general of the Indian Drug Manufacturer’s Association, said: “With the new order of the DCGI invoking Section 33(p) in place, it is not clear whether Madras high court stay could still stall the state drug controllers’ action to terminate licences. We are exploring other legal options to face the challenge.”
Venkateswarlu said his department may even appeal to the Supreme Court to ensure the action is implemented “as it is essential to improve the regulatory system and overall a matter of quality drugs in the country”.
The DCGI order aims to halt manufacturing and marketing of 294 combination drugs, which have not been tested in their blended forms.
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.
Maharashtra’s Food and Drug Administration (FDA) commissioner S.A. Momin has already initiated action following the DCGI’s alert.
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,” Momin said.
Gujarat’s FDA commissioner Subodh P. Adeshara said his team has issued notices to all the 370 manufacturers who hold around 1,800 licences for combination drugs in the state.