Drug Approval Case Study: Marketing of non-approved FDCs in India and DCGI’s FDC approval process request

Recently, the Drug Controller General of India (DCGI) found that 3 Indian drug makers are selling a combination drug to treat hypertension without mandatory prior regulatory approval. DCGI is the drug regulatory body in India and works centrally, taking care of the regulatory approval of the new drugs. 

Case Brief:

Three Indian companies 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.

DCGI action:

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 companies do not reply, regulatory body generally initiate legal action without making any further reference. According to the rules, the licences of these companies could be cancelled.

Also, 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.

Fixed Dose Combination Approval Process in India

According to the Drugs and Cosmetics Rules 1945, new drugs cannot be sold unless they are approved by the DCGI. Here as we are discussing in this case study, Azilsartan 40 mg+Chlorthalidone 25mg/12.5mg tablets being launched in market and 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.

How this is happening?

Fixed dose combination need to have DCGI approval (form 46). But many time commonly pharma companies exploring alternatives. The product has been supplied from certain state, with licence from state FDA (Food and Drugs Administration) instead of central (DCGI) approval.

What is Fixed Dose Combination?

A fixed dose combination contains two or more drugs combined in a fixed ratio of doses, available in a single dosage form.