The Indian Pharmaceutical Association (IPA) has urged the Union health ministry to make it compulsory for pharmaceutical industry to implement barcoding on medicine packs to ensure tracking and tracing of the products before framing a regulation to facilitate uploading sale data on the e-platform.
The IPA in a letter to deputy secretary (drug regulation), health ministry said that bar coding is now in practice in case of all consumer goods, hence it would not be a big problem to implement the same for medicines. Medicines being the most essential public goods, to ensure authenticity, reliability and quality, it is essential to barcode them for tracking purpose. This would also help promoting good dispensing practices at all retail points.
Its high time, the ministry looks into a plea of MSMEs, small retailers/wholesalers seeking manpower and infrastructure to implement barcoding, the IPA stated.
In the first phase, e-platform may be used for controlling sales by manufacturers and online pharmacy, if at all allowed. At this moment it would not be practical to implement it for stand-alone pharmacy especially in rural areas, said IPA general secretary Kaushik Desai.
As per the notification issued by health ministry on March 16, an e-portal will be set up wherein all manufacturers, stockists and retailers are required to register themselves and enter data relating to sale of drugs with batch number, quantity and expiry date through both online and by using mobile phones.
The e-platform will be developed and maintained by an autonomous body under the health ministry, said the circular.
Desai said that it is unnecessary to create another regulatory authority to regulate sale of drugs. The proposed regulation on sale of drugs shall be under CDSCO or DoP. More over, strengthening of existing regulatory system is necessary for regulating sales of drugs.
The concept of forming an e-platform for regulation of sales of drugs is an ideal one, but before its implementation, present circumstances like socio- economic conditions, infrastructure requirements should be considered. Issues such as, huge numbers of FDCs, strip-cutting may need to be sorted out first, which are the main deterrents to this concept.
The IPA general secretary said that the government's proposal to generate revenue for the body responsible for maintaining e-portal by charging transaction fee from pharmacies per prescription is in contradiction to its earlier stand. The government had not accepted the proposal of adding dispensing fees by the pharmacists since it would cause escalation of medicines cost and another fees cannot be charged for this purpose.
The revenue model proposed by the notification could comprise a small transaction fee of not more than 1% of the total cost of medicines subject to a ceiling of Rs.200 per prescription, to be paid online by pharmacies/e-pharmacies/wholesale /retail distributions, etc. A small amount of registration fee and renewal fee as may be determined by the government from time to time shall also be payable by manufacturers/ pharmacies/hospitals/clinical establishments, etc.