One of the important proposals considered during the 79th Drug Technical Advisory Board (DTAB) meeting held on May 16 was the introduction of a trace and track feature on the top 300 pharmaceutical brands in the Indian pharma market on a test trial basis.
The reasoning is that as these top 300 brands enjoy good brand recall and are repeatedly used by patients, counterfeiters would target these brands over others. Hence, the damage in terms of side effects of counterfeit medicines would be greater.
Taking this forward, the Drug Controller General (India) Dr S Eswara Reddy called for a meeting with pharma companies whose brands made up this list on June 25 to discuss the modalities for implementing the DTAB decision.
Based on the MAT data compiled by AIOCD AWACS, the list of companies is topped by Sun Pharma with 22 brands, while the Abbott Healthcare-Abbott India combine has 23 brands. Cipla has 17 brands on this list, while Alkem Laboratories, Pfizer, and Zydus Cadila have 15 brands each. Other prominent companies are GSK and Sanofi with 13 brands each, Aristo Pharma (12) and Mankind Pharma (9). Besides these big companies, many smaller companies have between 1-3 brands on this list.
The test trial envisages that these companies would voluntarily include a unique code on each pack of these brands, which presumably can be scanned by consumers, and checked against a database via a call centre or messages.
The move, though well intentioned, is bound to face some resistance. Firstly, for the industry, this would be an additional expense but one could argue that it was only a matter of time before patients, if not regulators, would demand such a feature.
Secondly, industry observers point out that patient groups and consumer activists would raise objections that such a feature should be mandatory not just for the top 300 brands but for all brands.
One could also question the rationale of choosing to do the trial using the criteria of which brands sell more, pointing out that some of these grossers would be multi-vitamins and supplements, which though vital, fall into the discretionary purchases rather than no-discretionary medicines like antibiotics, anti-malarials or anti-TB medication.
What would protect patients who choose not to buy these brands, either because they are not brand conscious enough or choose a cheaper alternative? This is anyway the case in non-metro markets, where it is easier to pass off lookalikes.
The DCG(I)’s office has clearly mentioned that these top 300 brands are merely a test trial. Therefore, it could be argued that based on the feedback and experience of this trial, trace and track could be introduced in a phase wise manner for all brands in the domestic market.
If this would be too much of a financial burden for pharma companies, maybe we could adopt some of the proven successful measures in countries with similar resource crunch issues. For instance, some countries in Africa have chosen to prioritise track and track mechanisms for medicines in therapeutic areas where they have a high disease burden. Anti-malarials and antibiotics could fall in this category, as would anti-TB drugs. This would impact maximum patients and those with serious communicable ailments.
The test trial can only go ahead once the logistics of providing a database of unique codes and a manned call centre or messenger service is in place. The June 25 meeting should hopefully throw some light on how the DCG(I) proposes to put this in place. Whatever system is used, it will have to be simple enough for consumers across India, non-metro areas included, to use.
Unlike most countries, India chose to mandate track and trace for pharma exports before domestic products. This was presumably to exempt smaller pharma companies who only serve the domestic market. After all, putting in place such a system calls for massive capital expenditure. For instance, smaller companies with 1-3 brands in the top 300 brands list will have to put in place dedicated packaging lines for these product packs.
While we await the outcome of the June 25 meeting, there is no doubt that at some point in time, India will have to put in place a reliable and simple mechanisms to detect fake medicines in the domestic market. The question is, can we avoid the complexity and yet get reliability? Any change is tough and will face resistance. Will good intentions carry the motion through?
DCG(I) Dr Eswara Reddy has to be congratulated for taking the first step. After all, as a Chinese proverb goes, a journey of a thousand miles begins with a single step.