Union government will need to define and prepare a list of over-the-counter (OTC) drugs with caution and fix a 48-hour validity period for prescriptions as per a new amendment to the Drugs & Cosmetics Act & Rules, said Dr BR Jagashetty, former national advisor (drugs control) to ministry of health & family welfare and former Karnataka drugs controller.

In the wake of the Drugs Consultative Committee meet to be held on July 24, 2015, with a focus on online pharmacy, Dr Jagashetty is of the view that the government is expected to include pharmaceuticals into online trade. Here legal and ethical issues have to be considered carefully since the safety of patient is most important.

Since OTC drugs do not require a doctor’s prescription and is bought by patients or their relatives to control early symptoms of influenza, diarrhoea, nausea, pain management, the government is expected to permit OTC drugs sale online, said Dr Jagashetty.

“Therefore suitable punishment clauses for any violations in online pharmacies are needed to be defined in the Drugs and Cosmetics Act. It could be incorporated under Section 18 which is the main clause prohibiting sale of various categories of drugs. This in turn helps to fix the punishment clauses. Clear-cut details of OTC drugs sale with and without prescription are also to be mandated. Online pharmacies will require dedicated permissions from the State Licensing Authorities and be registered with the CDSCO. This is on similar lines that of US FDA, EMA and UK MHRA norms for online pharmacies. The regulatory authorities should fix a registration and license fee of above Rs.1 lakh. The parameters for selection of online pharmacy traders would be based on a minimum 10 years experience in pharmacy business backed by three-year sales turnover details, said Dr Jagashetty.

The OTC list can be on similar lines that of international health insurance marketplace directive. Pharma manufacturers will need to provide details of OTC drugs to enable regulators to assess the quality and pricing parameters, he said.

Quoting an England and Wales study proving high fatality with indiscriminate paracetamol consumption, Dr Jagashetty pointed out that between 1993-97 paracetamol overdose led to poisoning causing 2,499 deaths. During this period, drugs containing paracetamol accounted for 500 deaths annually and about 20 per cent of all deaths from overdose and poisoning. Paracetamol was the only drug taken in 873 deaths and 488 deaths were caused by liver failure. Paracetamol as a single ingredient accounted for 1,451 deaths and as a combination drug ‘coproxamol’ reported 991 deaths.

Following this report, the government should undertake careful scrutiny of OTC drugs, said Dr Jagashetty.

Currently, online pharmacy practice violates Drugs & Cosmetics Act & Rules. But it is evident that the government would need to be in sync with global pharmacy practices. Strict audits and constant surveillance by a dedicated enforcement team would be the way forward for online pharmacy business, he said.