Industry Demands Exemption Of FDCs From New Package Insert Rules

Mumbai, 5 Nov 2018: The pharmaceutical industry has appealed to the Union health ministry to exempt fixed dose combination (FDC) drugs, being approved by DCGI as new drugs, from the proposed rules that mandate the industry to insert package in new drugs to provide information to the consumer.

The FDCs that were licensed by state licensing authority are now being approved as new drug by DCGI. These FDCs have been available in the market for a number of years and are technically not new drug. Hence exemption may be granted to this special category of 'New Drugs', said Indian Drug Manufacturers' Association (IDMA) in a representation to Union health and family welfare ministry.

Besides this, the industry is also looking for clarity on consumer and saleable unit of the new drug in the proposed draft rules.

The draft circular, GSR813(E) dated August 27, 2018 issued by the ministry, proposed to introduce additional condition in Form 45 and Form 46 of Drugs and Cosmetics Rules, 1945 as under: “Each saleable unit of the new drug shall accompany by the package insert for providing to the consumer.”

The industry body says the words “for providing to the consumer” need clarification as a package insert is invariably provided for information of a medical professional for prescribing the medication, which will be too technical for the consumer.

The proposal is to provide package insert along with 'each saleable unit of the new drug'. It can create difficulties due to interpretation that each saleable unit should be accompanied by the package insert. This means the regulatory officer may insist that every strip in a carton should have the insert literature, it opined. 

The package insert may be provided in case a saleable unit of bottle pack is delivered with an outer carton or a mono carton in case of strips, vials, injections etc. However, a pack normally contains 10 strips of 10 tablets/capsules each and one package insert is included in the pack, containing 10 strips of the drug. It is very rare that the customer buys a full pack of 10 strips. The challenge lies in providing package insert to consumers buying one strip out of a pack of 10 strips, said IDMA.

Also, this additional requirement will result in increase in package cost, adding to the price to be paid by the consumer, it added. 

The industry body has urged the ministry to consider their suggestions as above and modify the proposal for better compliance by industry, and for the benefit of all stakeholders. Pharmabiz