INDIA – India’s drug pricing authority has shortlisted the top 300 brands of drugs, which will have to put QR codes to their packages, in a bid to ensure authenticity and enable tracing.

The select drugs include widely used analgesics, pain relievers, anti-platelet, vitamin supplements, blood-sugar lowering medicines and contraceptive tablets.

Among the brands identified by the National Pharmaceuticals Pricing Authority (NPPA) are Dolo, Saridon Fabiflu, Ecosprin, Limcee, Sumo, Calpol, Corex syrup, Unwanted 72, and Thyronorm.

They were chosen based on their moving annual turnover value, as determined by market research firm Pharmatrac.

The list has been forwarded to the Ministry of Health and Family Welfare, which will make the necessary changes to the drug regulations.

According to a senior government official, the ministry asked the Department of Pharmaceuticals (DoP) in March to shortlist the top 300 drugs “so that we can incorporate the same in the draft notification and make necessary amendments in the drugs rules for its implementation.”

Earlier this year, the union health ministry notified the guidelines, saying “every active pharmaceutical ingredient (API; bulk drug) manufactured or imported in India shall bear a quick response code on its label at each level, packaging that store data or information readable with software application to facilitate tracking”.

API is the core ingredient for manufacturing a drug. If it is fake or sub-standard, then the whole medicine quality is jeopardized Industry insiders expect the new requirement to hurt medium and small enterprises.

A major chunk of APIs is imported to India from China. However, the government is taking measures to ensure that India is able to manufacture most of it indigenously.

The Indian government has been trying to introduce QR codes since 2011. Pharma companies and lobby groups had expressed concerns over multiple sets of directions regarding tracing and tracking being issued by various departments and had asked for a single QR code system.

“It’s not easy for the small and medium enterprises to make such changes on packaging as it will require a lot of extra effort and money,” said an industry expert on the condition of anonymity.

The changes in the drugs rules were made under the Drugs and Cosmetics Act, 1940, after consultation with the regulator’s subject expert panel— the drugs technical advisory board. The initiative will help easily distinguish between the real and fake drugs.

India’s drug regulatory authority is also in the process of amending the Drugs and Cosmetics (D&C) Rules, 1945.

Further afield, Brazil has also enacted new law on May 12, 2022 (Law No. 14,338/2022) requiring that medicine package inserts will have to be provided in digital format, in addition to the existing written format.

The law will require that a QR code be included in package inserts in all drugs for the purpose of allowing consumers to have access to the information in digital format.

The purpose of the package insert (also known as “prescription drug product insert” or “professional labeling”) is to provide detailed drug information compiled and distributed by the drug manufacturer.

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