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India’s bid to bring OTC drug regulations gains momentum; 3-

member panel in place to examine expert recommendations
Arun Sreenivasan, New Delhi
Friday, March 1, 2019, 08:00 Hrs   [IST]
The Central government has formed a new three-member sub-committee to expedite efforts to define over-the-
counter (OTC) medications that can be sold in the country without prescriptions and put in place a regulatory
framework for them.

The panel, constituted by the Drugs Consultative Committee (DCC), will review an earlier report submitted by a group
of experts that details various aspects of OTC drug trade including their definition, initial list of medicines,
manufacturing and labeling regulations, classification and approval process. The new sub-committee is headed by
Haryana Drugs Controller NK Ahooja and has Karnataka Drugs Controller Amaresh Tumbagi and Deputy Drug
Controller at Central Drugs Standard Control Organisation R Chandrashekhar as members.

At its recent meeting, the DCC is learnt to have discussed the report at length and has decided that a detailed
examination of the recommendations by a dedicated team is required to take further action.

While consumers benefit from well-defined OTC regulations that support a favourable environment for responsible
self-medication, India currently lacks these rules thereby compromising patient safety. A well-regulated OTC
framework is key to universal health coverage as it helps improve access to medicines, say industry observers.

However, many experts also draw attention to dangers of self-medication and the need to raise awareness of the
rules concerning OTC medicine delivery and consumption. “The coming months will see stricter implementation of
quality standards and increased awareness of the risks of online drug sales. OTC drugs need greater regulation to
prevent unmonitored use and abuse,” Atul Nasa, Head of Office and Controlling Authority, Delhi Drugs Control
Department, said during a session at the recently concluded Indian Pharmaceutical Congress in Delhi.

While attending a panel discussion at the event, Dr. R Chandershekhar, Deputy Drugs Controller at the CDSCO, also
echoed Nasa’s views, stressing the importance of compliance, safety and risk control standards.

Once the sub-committee report is finalised, the government is expected to introduce a new category of OTC
medicines such as anti-allergy, antipyretic and anti-emetic drugs that can be dispensed by pharmacists without a
prescription. The list may include muscle relaxants, decongestants, anti-inflammatory drugs, antacids, external
preparations for skin and hormonal contraceptives.

A recent study on India’s OTC policy by the Organisation of Pharmaceutical Producers of India has highlighted the
need to create a robust regulatory framework for such medicines by including a separate schedule in the Drugs and
Cosmetics (D&C) Act. Currently, in India allopathic drugs which are safe to be dispensed mostly fall under Schedule
H and H1 and require a prescription as per the D&C Act.