Mumbai: The Madras high court has admitted a counter affidavit filed by the drug controller general of India (DCGI) asking it to vacate a stay the court had granted against a recent order of the regulator to ban the so-called combination drugs that are licensed by state authorities.
The regulator in October had asked Central and state drug licensing authorities to cancel licences issued to drug firms to make and sell combination drugs, which currently account for revenues of about Rs4,000 crore.
A combination drug is formulated by combining two or more drugs meant for curing different diseases. Since these drugs are individually approved by the regulator following necessary tests, the states used to issue licences for the combined drugs, which the drug makers launched in the market under new brand names and claimed multiple therapeutic benefits to boost sales. Though this practice has been growing fast, there are no prescribed tests or institutional mechanism to check the drugs in the combined form to prove their safety and efficacy.
M. Venkateswarlu, drug controller general of India
This has triggered the action by the Centre to recall all the state licences and approve those drugs afresh after appropriate tests. While the state regulators initiated action, a few individual drug makers and the Confederation of Indian Pharmaceutical Industry, or Cipi, a trade body of small- and medium-sized pharmaceutical firms, fought the government’s regulatory fiat.
The court’s stay was granted to the industry following two petitions by Cipi and three other petitions by individual companies in Tamil Nadu and Puducherry.
Drug controller M. Venkateswarlu said his office’s counter affidavit covers all the five stay orders and added that he expects the court to rule after it reopens in January from a recess.
“We have explained the technical and scientific reasons by which the department action was initiated and how important is the implementation of the same for the larger interest of the public and moreover the safety of patients,” he added.
On 30 November, the Central Drugs Standard Control Organization, or CDSCO, the department headed by the drug controller, issued a special order making it mandatory for state drug controllers to withdraw manufacturing licences for all combination drugs issued in their respective states.
The Madras high court stay orders are currently applicable in five southern states of Tamil Nadu, Karnataka, Kerala, Andhra Pradesh and Puducherry.
CDSCO has already filed caveats in high courts in Himachal Pradesh, Punjab, Haryana and Uttarakhand to pre-empt stay appeals by bodies such as Cipi.
Meanwhile, the country’s top drug makers including Ranbaxy Laboratories Ltd, Cipla Ltd, Nicholas Piramal India Ltd, Sun Pharmaceutical Industries Ltd and several others, who sell these combination drugs in at least 3,000 brands, say they have applied for fresh licences from the Centre.
Venkateswarlu said the department has so far received 186 applications, of which 50 have been already rejected due to inadequate documentation to prove the quality andefficacy of the drugs.