New Delhi: The Drug Controller General of India (DCGI) may initiate legal action against three local drug makers for selling a combination drug to treat hypertension without mandatory prior approval.
An inquiry has been initiated by the Central Drug Standards Control Organisation (CDSCO) against Zydus Cadila, Eris Lifesciences Pvt. Ltd and Intas Pharmaceuticals Ltd.
In a show cause notice sent on 13 December, DCGI asked these companies to reply within 10 days, failing which legal action will be initiated under the provisions of Drugs and Cosmetics Act, 1940 and rules 1945. The drug regulator has also directed the companies to withdraw their products from the market and submit the details of quantity recalled along with documentary evidence. Mint has reviewed the copy of the show cause notice.
“The companies have been found to have placed a new drug formulation in the market without obtaining permission which is in contravention of Drugs and Cosmetics Act 1940 and rules thereunder. The companies have been asked for their submission; if they do not bother to reply, we will initiate legal action without making any further reference. According to the rules, the licences of these companies could be cancelled," said a person aware of the matter, on condition of anonymity.
According to the Drugs and Cosmetics Rules 1945, new drugs cannot be sold unless they are approved by the DCGI. The CDSCO in November received a complaint from Hetero Drugs Ltd that it found the fixed dose combination of Azilsartan 40 mg+Chlorthalidone 25mg/12.5mg tablets being sold without the required approval. The drug has so far been approved for launch only in the US and Canada. According to the clinical trials guidelines of the CDSCO, if the product is approved elsewhere and not in India, phase III clinical trials and bio-equivalence studies are required to establish its safety and efficacy on the Indian population. The complainant alleged that the product had been launched without mandatory trials being conducted.
Zydus Cadila and Intas Pharma did not respond to an email sent by Mint till the time of going to the press.
Eris Lifesciences said that they “do not manufacture or market the mentioned combination and it seems there is an error". When contacted, the DCGI office confirmed that a notice has been sent to the company.
The complainant—Hyderabad-based Hetero Drugs—had in December 2015 applied for manufacturing and marketing approval of the fixed dose combination drug. The drug advisory committee, which consists of experts on the subject, recommended that the company conduct bio-equivalence and clinical trials in July 2017. The company completed the bio-equivalence study and submitted its report to the DCGI in September 2017. The study is done to measure the rate and extent of absorption of drugs in the human body.
When the trials were still on, the company found that the combination drug is already available in the market. “We noticed that the above mentioned combination was launched into the market by various companies without having DCGI approval (form 46). The product has been supplied from Uttarakhand, with licence from state FDA (Food and Drugs Administration)," read the complaint. Mint had reported it in November last year.
A fixed dose combination contains two or more drugs combined in a fixed ratio of doses, available in a single dosage form. Hetero Drugs said in its complaint it had spent a lot of money on the trials and asked DCGI “if the clinical trials are required on Indian patients or should we apply to get final permission on priority".