Industry split on drug barcoding from July

Every Indian-origin drug will be counted and have its history documented soon. From July, each drug exported will have its packaging adequately laced with bar codes so that at any point during the supply chain or afterwards, if doubts are cast on the quality or efficacy of an India-made drug, the roots of the product can be traced back from the pharmacy to the factory and leakages and accountability fixed.

The notification to mandate such barcoding has come from the ministry of commerce earlier this year even as the drug controller general of India (DCGI) plans to make such coding mandatory for all drugs-even those distributed and sold within the country-a decision challenged by drugmakers in the Allahabad High Court.

While a few top pharma firms have either been neutral or have favoured the proposal, many midcap players are opposing it vocally and most small players have termed it as a death knell for their business. The top domestic pharma firms which compete with the global leaders in several regulated markets in the business of branded generics aim to keep themselves abreast with technological advances.

As a track-and-trace technology would make detection of spurious drugs easy, a few top firms that are entering or have entered branded business would eventually find it useful. Most importantly, the US Food and Drug Administration, which regulates the largest drug market in the world, has also begun discussions among stakeholders to put in place a technology that can track and trace drugs throughout the supply chain.

However, a majority of the 3,500 drug exporters in the country have resisted the move stating that it is practically impossible to implement the standards of barcoding notified by the government within a span of few months. They say the transition time that the government has granted them to shift from manual packing to automation needs companies to incur huge investments. This, in turn, would increase input costs significantly and take away the cost-advantage that Indian companies are known to offer in a highly competitive international market.

“We are in talks with the government to implement the plan in a phased manner and also start it with mandating only on tertiary packing (cartons) instead of all levels of packaging,” said PV Appaji, executive director, Pharma export council. Indian drug manufacturers’ association has sought the deadline of implementation be postponed from July 2011 to July 2013 and has demanded a clear exclusion of primary packing material such as bottle, blister and vial from barcoding.

“The text matter on the label of each strip or vial has to be approved by the individual importing country. So, changes would first have to be approved by the regulator of importing countries,” an IDMA representation apprised the ministry. Therefore, the drugmakers are insisting on limiting the implementation of technology to tertiary packaging, that is the carton. In protest, the SME Pharma Industries Confederation has shot off a letter to the Prime Minister seeking withdrawal of the notification. A few industry estimates peg investments required for the needed upgradation per packaging line to be close to R1 crore. Additionally, there would be recurring expenses.

Officials, though, maintain that the step would put at rest all baseless speculation of India being a source of spurious drugs and build a formidable reputation of the country’s drug industry. The government also expects the step to clear other illegal channels of trade, for instance, spurious drugs found in Nigeria in 2009 that were labelled ‘made in India’ were finally traced back to China. The industry argues that implementing such a step to avert bad reputation is an indirect admission of guilt of a crime they have not committed. Alongside US, many other European countries such as Sweden, Belgium, Turkey are discussing or pilot-testing several track-and-trace technologies. But, the main challenge before the regulators is to attain an international standardisation of compatible technologies so that global networks of drug supply chain can be monitored seamlessly.

Kamal Sharma

managing director, Lupin

It is definitely a positive step forward in addressing the menace of spurious and substandard drugs and the move shows the good intent of the government to ensure safe and traceable drug-supply chains. However, whichever technology is made mandatory, it is important that the entire history of the drug should be established through electronic pedigree or what is popularly known as e-pedigree. The e-pedigree tracks movements of pharmaceutical products throughout the supply chain from the factory to pharmacy and each trade and transaction that happened through the process is documented.

That would be effective in fixing accountability at different levels. Anything lesser than that, simply superficial barcoding or hallmarks would defy the purpose that the government is aiming at. Finally, how successful the move proves to be would depend on how effectively it is implemented.

NR Munjal

managing director,Ind-Swift Labs

It has been proven through studies by the independent bodies and government that fake drugs constitute an insignificant part of the domestic drug market, what is the rationale behind the urgency in implementing a track-and-trace technology? Also, close to 70% of packaging happens manually here. For us to be compliant to the new rule, the entire industry has to adopt automation for packaging and that would translate into formidable expenses. This is bound to affect the Indian industry adversely in terms of the cost advantage that it is known to offer, in the international market. Within the country, the drug prices would also shoot up. Also, isn’t it a better idea to make it mandatory for the chemist to write the batch number and other details on the receipt, so that the drug can be traced back. India has more than six lakh chemists and if they do not have bar code readers what is use of bar code?

You can read the original article on the Financial Express website