The All India Drug Action Network (AIDAN), involved in advocacy for rational drug policy and use, has urged the Union Health Minister to amend the Schedule ‘H’ under the Drugs and Cosmetics Act, 1940, to enable Janaushadhi Kendras to dispense generic substitutes of branded prescription medications.
In a letter dated June 11 to the Health Minister, the network has also urged that an expert panel be set up to assess the feasibility of allowing generic substitutions for prescription drugs as per the recommendations of the Central Drugs Standard Control Organisation (CDSCO) Technical Advisory Board.
This comes in the wake of the Indian Pharmaceutical Alliance (IPA) opposing a proposal to allow the government-run Janaushadhi Kendras to dispense substitutes of prescription medications.
Amendment to Act
The CDSCO has been mulling over a proposal to make changes in the Drugs and Cosmetics Act and its associated regulations to allow the substitution of drugs specified under schedules H, H1, and X with a view of promoting “quality generic medicines at affordable prices.” Schedule H of the Act includes general prescription drugs while Schedule H1 includes 3rd and 4th generation antibiotics, anti-tuberculosis drugs and certain psychotropic medicines.
Earlier this year, the CDSCO’s Drug Technical Advisory Board had recommended constituting an expert panel to assess the feasibility of allowing generic substitutions for these prescription drugs, provided they match the original in “substance, strength, and dosage form.”
Gopal Dabade from Drug Action Forum, Karnataka, that is part of AIDAN, said that the IPA, in its opposition to the proposal, has claimed that “if the recommendation was accepted for Janaushadhi stores, it would open floodgates of similar demands by trade channels, such as general pharmacy stores, which will not be in the interest of patients.”
“However, we would like to point out that permitting Janaushadhi shops to substitute brands with generic name medicines would help bust the myth that only renowned brands are of good quality. This is what the IPA does not want,” he said.
Legal backing
Prasanna Saligram from Sarvatrika Arogya Andolana Karnataka (SAAK), that is part of AIDAN, said although several Janaushadi stores are dispensing substitute generic drugs to renowned branded medicines, the proposed amendment to Schedule ‘H’ will give it legal backing.
“AIDAN believes this would certainly be in the interest of patients, provided there is an equally emphatic demand from society at large. The functioning of the State Drug Control Authorities should be radically improved with a quantum jump in the number of drug inspectors as per the Mashelkar Committee report. This will result in reducing the proportion of Not Standard Quality (NSQ) medicines in India,” Dr. Dabade said.
“IPA’s statement perpetuates the myth that NSQ medicines are made only by small companies. It overlooks the fact that the National Drug Survey has shown that many of the renowned brands have also been found to be NSQ,” he added.
Published - June 15, 2024 12:09 am IST
