The All India Chemists and Distributors Federation (AICDF) has urged the health ministry to clearly define over the counter (OTC) drugs with a specific symbol on the pack, guidelines on promotion of products and bring them under price control to check overcharging and unethical profiteering.
Joydeep Sarkar, general secretary of AICDF said, OTC medications should have a specific earmark, symbol or detail on pack, box or case to classify it separately with the goal that consumers can easily identify it. The formulation containing no less than 20 percent active pharmaceutical ingredients should be put under the purview of OTC medicine. In order to avoid from returning drugs having 20 percent API or short of what it after the expiry date, the makers regularly put them under dietary supplement.
Sarkar said Criteria, conditions, guidelines, and factors should be categorized for determining as well as converting over any formulation as OTC medicine. To consider a formulation as OTC medicine- value, volume and/or Eon of any formulation should not be any of such criteria. Formulations once under the Schedule H or H1′ drugs or under the NLEM can’t be converted over ever as ‘OTC drugs’. In the past we have seen levonorgestrel (I-Pill, Unwanted 72 and etc), in spite of being Schedule H suddenly came under OTC regime with no strong logic for such conversion.
He said, only pharmacies should be allowed to dispense OTC medicines to ensure its safe and rational use. It is noted that OTC drugs are available at establishments for headaches, muscle strains, minor skin burn, cold, cough other than pharmacies. It often encourages the non-judicious use of the OTC medicines resulting about serious health outcomes.
Guidelines on the promotion of OTC drugs should also be set up to regulate promotion and distribution of products lacking therapeutic properties for the sake of OTC drugs. Statutory notices if applicable should be mentioned on the packing, in the notice of these OTC medicines.
Formulation violating the provisions of the Magic Remedies Act’ must not be under the purview of OTC medicine.
He opined, price control of OTC medicines is a crucial part and the options of DPCO-2013 should be applicable on such range of formulations with amendments and inclusions if required. Form V option should be applicable to OTC medicine for restricting overpricing of formulations for the welfare of common citizens.
He added, since OTC medicines are generally not advised by doctors, those formulations can be sold against request on counters with/without chits. No specific education will be required for dispensing OTC medication from the retail or wholesale drug stores, but the owner of the licensed premises should have the right to sell them to the consumers.
AICDF has represented to the ministry with their huge number of suggestions following a notification by the panel looking into categorisation of OTC medications.