The All India Chemists and Distributors Federation (AICDF) has urged the health ministry to clearly define over the counter (OTC) drugs with distinguishing mark on the pack, guidelines on promotion of products and bring them under price control to check overcharging and unethical profiteering.
OTC medicines should have specific earmark, symbol or specification on pack, box or case to classify it separately so that consumers can easily identify it. The formulation containing at least 20 per cent active pharmaceutical ingredient should be put under the purview of OTC medicine. In order to avoid returning drugs having 20 per cent API or less than it after expiry date, the manufacturers most often put them under dietary supplement, said Joydeep Sarkar, general secretary of AICDF.
Criteria, conditions, guidelines and factors should be categorized for determining and/or converting any formulation as OTC medicine. Value, volume and/or Eon of any formulation should not be any of such criteria to consider a formulation as OTC medicine. Formulations once under the ‘Schedule H or H1’ drugs or under the NLEM cannot be converted ever as ‘OTC drugs’. In the past we have noticed levonorgestral (I-Pill, Unwanted 72 etc), despite being Schedule H drugs suddenly came under OTC regime with no strong logic for such conversion, said Sarkar.
Molecules with minimum risks and threat of side/adverse effects should not be under the list of OTC medicine. Permission of CDSCO should be obligatory for introducing any OTC medicine under a separate format or Form after including such provision in DPCO.
Only pharmacies shall be allowed to dispense OTC medicines to ensure its safe and rational use. As OTC drugs are non prescription drugs, any establishment whether it is pharmacy or grocery shop can sell them. It is observed that OTC drugs for headaches, muscle strains, minor skin burn, cold, cough are available at establishments other than pharmacies. It often encourages non judicious use of the OTC medicines resulting in serious health consequences, he said.
Guidelines on promotion of OTC drugs should also be put in place to regulate promotion and distribution of products lacking medicinal properties in the name of OTC drugs. Statutory warnings if applicable should be mentioned on the packing, in the advertisement of these OTC medicines. Formulation violating the provisions of the ‘Magic Remedies Act’ must not be coming under the purview of OTC medicine.
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 on OTC medicine for restricting over-pricing of formulations for the welfare of common people, he opined.
The minimum trade margin on OTC medicines should be more than ethical formulations since OTC medicines have least marketing cost. They are often promoted through media rather than sales force which is less expensive. As of now drug wholesalers and retailers' trade margin on OTC drugs hover around 6-10 per cent and 15-20 per cent respectively. It should be raised to 10-15 per cent for wholesalers and 20-30 per cent for retailers, said the AICDF general secretary.
Since OTC medicines are mostly not advised by physicians, those formulations can be sold against demand on counters with/without chits. No specialized education will be required for dispensing OTC medicine from the retail or wholesale drug stores, but the owner of the licensed premises should have the right to sell them to the consumers, he added.
No separate license but the conventional drug license (both wholesale & retail) should be considered as obligatory to sell, stock and distribute OTC medicine.
AICDF has represented to the ministry with their slew of suggestions following a notification by the panel looking into categorisation of OTC drugs.
The panel set up by the government had written to stakeholders seeking suggestions from them in this regard.