Experts urge DCGI to direct state DCs for action against altering components without changing brand names

Chennai, November 16, 2022:

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.

According to them, this unethical practice of the manufacturing and marketing companies has been continuing in the country for the last 20 years, which is confusing the total stakeholders. This tendency has to be discouraged without delay considering the health of the people.

Sources spoke to Pharmabiz in anonymity have revealed that the CDSCO and the state drug controllers or the licensing authorities are fully aware of these unethical practices, but they seem to be averse to act up on legal measures to prevent the companies from doing this illegal and unscrupulous business strategies. Sources said retaining one brand name even after changing the active constituents with 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 organisations working in health area, the DCGI on May 16, 2019 issued a circular to all state DCs and zonal and sub-zonal officers of the CDSCO to take legal action against those companies who follow unprincipled methods in marketing and manufacturing processes. In the letter the drug controller general had wanted the enforcement officers to ensure that contents-changed formulations should not be marketed in the country in their old brand names because it confused both the prescribers and the consumers. As a stern action, the national drug regulator had also wanted the licensing authorities not to permit the sale of pharmaceuticals with changed compositions without changing the old brand names.

The health activists now allege that despite strict directions from the central regulatory agency no state regulator has so far followed the direction of the national regulator as the unfair business practices are still happening abundantly everywhere in the country. They said they will apprise the DCGI about the consequences that may affect the health of the society due to this unethical business practice being followed by both manufacturers and marketers.

A retired enforcement officer who is presently working with health organisations in Kolkata said there are five products such as Itraconazole capsule, Esomeprazole gastro-resistant tablets IP, Albendazole Tablets IP, Metronidazole Oral Suspension BP and Pantoprazole Injection 40 mg which are marketed under a particular brand name. Quoting the DCGI’s earlier remarks that this issue was discussed many times in the drug consultative committees (DCC), he said alteration in the brand name is not only misleading but also resulting in undesirable pharmacological effects because the consumer would take the formulations assuming that he is taking the same medicines 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 are sold under the name ‘Corex’. These are all misleading the patients and sometimes even the doctors. He said it is the duty of the DCGI to take urgent measures to stop this kind of illegal medicine marketing considering the health of the people of the country as there are chances to be misguided and misled by poor people. According to him, medical shops manned by unqualified pharmacists are likely to commit mistakes while dispensing the drugs without knowing the contents of the brands.PharmaNews