GOI amends Rules to Tackle Duplicacy of Drug Brand Names

The Ministry of Health and Welfare under the Government of India undertakes consistent endeavors to ensure the proper updating of the existing rules related to the manufacture and marketing of drugs and cosmetics.

In this wake, the ministry recently made some amends to the Drugs and Cosmetic Rules 1945. These rules can be called the Drugs and Cosmetics (Thirteenth Amendment) Rules, 2019 and are concerned with the branding of relevant drug products.

These rules were published in the Gazette of India on 6th November 2019 and have since come into effect. This new rule applies when an applicant intends to market the drug under a brand name or trade name.

According to the new rule - The applicant must submit an undertaking using form 51 to declare that the proposed brand name/trade name is not already in existence with respect to any drug in the country to the best of search and his knowledge. So it doesn’t cause any confusion in the market. The tools for search and confirmation to be used can include a central database for brand name or trade name of drugs maintained by Central Drugs Standard Control Organisation, literature and reference books on details of drug formulations in India, and the internet.

Why was this new rule created?

The Indian market is crowded with drug manufacturing companies that churn out literally thousands of medicine brands. Different companies market the same salt combination of drugs using different names. The brand name of a drug is the easiest way to identify its compositions and is often used by the general public for minor medical issues.

Additionally, nearly all medical practitioners prescribe branded medicines rather than generic compositions. This also means that most doctors identify medicines by their brand names.

However, due to a large amount of existing and upcoming medicine brands in the market, the chances of duplication of brand names have risen ten folds. Hence to eliminate any confusion or delusion regarding a medicine brand, this new sub-rule was formulated.

How will this rule affect the market?

This new rule is set to positively affect the market. First of all, it will ensure that there is no duplicity of brand names among different medicines sold on the market. Which will eventually eliminate all confusion regarding brand names?

There have been several reported cases where illegal or unidentified/non-registered drug manufacturers were using duplicate or similar brand names to fool their way through customers. Moreover, it will facilitate better identification of drugs at all levels.

Medical Device Regulation India