India coding plan for domestic medicines expected soon

India has reiterated plans to extend the use of unique codes on medicine packs - currently mandated for exports - to include drugs sold within its borders.

The Drug Controller General of India (DCGI) has said the country intends to add serialised codes to domestically-distributed medicines in order to protect citizens from spurious or falsified medicines, according to a report by the IANS news agency.

India's Directorate General of Foreign Trade (DGFT) has already set up a coding system for exported medicines which requires unique serial numbers to be added to medicine packs, the relationship between primary, secondary and tertiary packaging to be recorded (aggregation) and data to be uploaded to a Drug Authentication and Verification Application (DAVA) portal.

A year ago, India's government announced its intention to extend this system to domestic medicines in a draft notice issued by the Ministry of Health and Family Welfare (MoHFW).

Citing DCGI G.N. Singh, the IANS report says that a coding system that will allow people to check the authenticity of medicine packs using mobile phones will emerge "within a couple of months" - presumably referring to the timeline for formal publication of the requirements.

Pakistan is reportedly also developing a system which will allow consumers to authenticate medicines that observers suggest is quite similar to the Indian proposals.

Nakul Pasricha of PharmaSecure, who is vice president of India's Authentication Solution Providers Association (ASPA), told SecuringIndustry.com that the intention is to develop a harmonised version of the DGFT regulations for exported drugs.

In India, exported drugs are the responsibility of the DGFT, while domestic sales are governed jointly by the MoHFW and the Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers.

"While the MoHFW had been evaluating regulation for the domestic market a few years ago, pharmaceutical manufacturer associations made representations asking for a harmonised regulation to facilitate implementation," explained Pasricha.

"The DCGI's recent comments indicate that they may be moving quickly towards issuing this regulation," he added. "We have been pushing hard for such measures, so it is gratifying to see some action from government."

That sentiment was echoed by former Kezzler executive Avi Chaudhuri, who is now spearheading Systech's expansion in Asia.

"There has been some political movement in India over the past couple of years to set up a drug protection program for the domestic market, the argument being that if exports are protected then why should the same not apply to the domestic supply?"

A consumer rights group actually moved the Allahabad High Court to impose just such a requirement on the MoHFW, further to which a task force was set up to advise the ministry on the best way forward, he added.

"I expect some more such pronouncements largely as a 'trial balloon' to gauge the response from industry, with the firm belief that a domestic programme is soon to be announced," said Chaudhuri.