Affordable drugstores may get a boost
› Pharmacists are not allowed to substitute one brand of a drug with another because even with the same compounds, manufacturing processes may be different for different brands that may result in varying efficacy DR CM GULHATI, an expert on drug regulations
NEWDELHI: India’s apex drug regulator is considering amending the Central Drugs and Cosmetic Rules to make way for government-run affordable drugstores called Jan Aushadhi Kendras to dispense generic medicines for branded prescriptions.
The drug controller general of India’s (DCGI) decision is in line with the government’s policy to stop profiteering by promoting generic drug stores that are priced a fraction of the cost of branded drugs.
Under the Pradhan Mantri Bharatiya Janaushadhi Pariyojna, at least 4,000 Jan Aushadhi Kendras are franchised to sell more than 900 medicine and 150 surgical products at affordable prices. Rule 65 (11-A) of the Drugs and Cosmetics Rule, 1945, states that the person dispensing a prescription cannot substitute drugs listed under Schedules H, H1 and X with any other preparation. These schedule lists include strong antibiotics, pain medications and psychotropic drugs that cannot be sold without prescriptions.
The matter was discussed the 81st meeting of the drug technical advisory committee (DTAB) that was held late last month. “In view to improve the effectiveness of Jan Aushadhi Scheme through promotion of generic medicines, it is proposed to amend the rule 65 (11-A) to allow Jan Aushadhi Kendras only for substitution of medicines,” said the detailed agenda of the meeting.
The committee is deliberating inserting the following condition in the rule, “Provided that nothing in this sub-rule shall apply to the sale of the medicines labelled as Pradhan Mantri Bhartiya Janaushadhi Pariyojana under Jan Aushadhi scheme.”
To promote the use of cheaper generic medicines, the Central Drugs Standard Control Organisation had earlier this year made it mandatory for drug stores to have a separate shelf to display generic medicines.
The health ministry, however, felt that this would not bring the desired benefits to patients and referred the matter back to DTAB, which is now deliberating whether there is a need for a separate shelf with the sign, “Generic Medicines in Proper Names are Available”.
Amending the rules is not necessary, said an official from the ministry of chemicals and fertilisers, which oversees the Jan Aushadhi Scheme. “The amendment is not necessary as the Jan Aushadhi stores do substitute the branded medicines for generic ones. The interpretation of the clause is that a shop may not substitute an ibuprofen drug prescribed by the doctor for a diclofenac, which is also a pain medication. But, a crocin can be substituted for generic paracetamol because the compounds are the same,” said an official, on condition of anonymity as no official communication was received from the health ministry that governs the implementation of drugs and cosmetics act.
This view was supported by independent experts as well.
“According to the rules, the pharmacists are not allowed to substitute one brand of a drug with another because even with the same compounds, the processes of manufacturing may be different for different brands, which may result in varying efficacy. The rules, however, allow for substitution of generic drugs for branded ones,” said Dr CM Gulhati, an expert on drug regulations and the editor of Monthly Index of Medical Specialities.