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Health ministry considering to amend D&C Act to implement track & trace system for domestic products

Laxmi Yadav, Mumbai
Tuesday, October 18, 2016, 08:00 Hrs  [IST]

The Union health ministry is actively considering to amend the Drugs & Cosmetics Act to facilitate implementation of barcoding on domestic pharma products to curb counterfeiting.

The ministry has been holding parleys with key stakeholders including pharma companies and drug trade bodies for a long time with an aim to build consensus among them before introducing amendment to D&C Act to implement track and trace system for domestic market. A couple of months back, DGCI called a meeting of industry bodies OPPI, IDMA, IPA and trade body like AIOCD to discuss the implementation of domestic barcoding.

AIOCD has consented to barcoding implementation to ensure pharma product quality. A section of pharma companies has also agreed to it. Efforts are being made to get others onboard for the same. The consensus building will take some time considering the diversity of the problems.

Unless the government makes it compulsory for domestic drug manufacturers to implement barcoding on pharma products, nothing will happen, said anti-counterfeiting experts like ACG Worldwide chairman Ajit Singh.

Considering insufficient manpower coupled with weak regulatory system in some states in India, counterfeiting drugs are quite prevalent. To overcome it, implementation of track and trace system is need of the hour. For this, the government has stepped up efforts to amend D&C Act. The track and trace system for the domestic pharma products will be applicable for all the three levels of packaging i.e. primary, secondary and tertiary, said Gujarat FDA commissioner, Dr Hemant G Koshia, who chaired track and trace committee set up by the health ministry in 2012 following Allahabad High Court order.

The manufacturers will have to incorporate bar coding and Unique Identification Number (UIN) in every pack of medicine. For this they have to make some changes at packaging level under GMP guidelines. It is cost effective solution. With disruptive technologies coming to the market, the anti-counterfeiting solutions which may be costly initially but will be available at cheaper rate in long run, said Dr Koshia.

Initially industry perception was not favourable due to high printing and labelling technology cost. With the latest technology coming up, their perception has changed. Most pharma companies in Gujarat which is home to 600 pharma units affiliated to IDMA are ready for barcoding, said Dr Koshia.

The Koshia committee in its report suggested a slew of measures to implement barcoding on domestic pharma products including amendment to Drugs and Cosmetics Act. The panel also talked about implementation of barcoding in phased manner where 200 big companies would be targeted in the first phase spanning over a year. On its success, 2,000 companies would be targeted in the second phase spanning over two years. Rest would be targeted in third phase spanning over two years.

Acting on the committee recommendation, the health ministry had issued draft notification for implementation of bar code on domestic medicines on June 3, 2015. The government proposed to amend the D&C Rules to authenticate the genuineness of drugs through effective tracking of the products right from its production stage to the delivery point. The Drugs Technical Advisory Board has been consulted for carrying out the amendments in the said rules.


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