Altering the contents of formulation without changing brand names

Sources said retaining one brand name even after changing the active constituents to other therapeutic categories is a common practice in India.

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Medicine
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Last Updated on November 18, 2022 by The Health Master

Health activists and a group of retired enforcement officers from across the country have urged the Drugs Controller General of India (DCGI) to issue a direction to the state regulators and the CDSCO’s zonal offices to act on the circular the DCGI issued on May 16, 2019, for legal action against manufacturers who alter the contents of formulations without changing the brand names.

This tendency has to be discouraged without delay, considering the health of the people.

Sources said retaining one brand name even after changing the active constituents to other therapeutic categories is a common practice in India.

This is creating myriad health problems for the people and many often the misled are the poor people.

Following complaints from health activists in Delhi and Kolkata and also from organizations working in the health area, the DCGI on May 16 issued a circular to all state DCs and zonal and sub-zonal officers of the CDSCO to take legal action against those companies that follow unprincipled methods in marketing and manufacturing processes.

The drug controller general had requested in the letter that formulations with changed contents not be marketed in the country under their old brand names because it confused both prescribers and consumers.

The national drug regulator also requested that licensing authorities not allow the sale of pharmaceuticals with changed compositions without changing the old brand names as a stern action.

A retired enforcement officer who is presently working with health organizations in Kolkata said there are five products that are marketed under a particular brand name. They are as follows:

  • Itraconazole capsule,
  • Esomeprazole gastro-resistant tablets IP,
  • Albendazole Tablets IP,
  • Metronidazole Oral Suspension BP,
  • Pantoprazole Injection 40 mg.

He said an alteration in the brand name is not only misleading but also results in undesirable pharmacological effects because the consumer would take the formulations assuming that he is taking the same medicines as with the earlier compositions.

Similarly, one retired enforcement officer in Chennai said there are more than five products under the brand name “Dolo” and more than 15 products sold under the name “Corex.”

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