India is committed to adoption of modern technology for ensuring supply chain integrity of medicines besides creating strong regulatory framework for enforcement of newly introduced specific regulations, said S M Mudda, director – global strategy (technical), Micro Labs Limited and chairman, Regulatory Affairs Committee, IDMA Mumbai
 
There has been a paradigm shift in the industry's approach for determination of quality and safety of drug products going beyond the end product testing and GMP compliance during manufacturing. The industry is moving towards the desired state of Achieving Product Realization (APR) that require the quality attributes appropriate to meet the needs of patients and healthcare professionals, Thus, supply chain integrity has become one of the essential quality attributes of medicines and the industry focus is on adopting appropriate anti-counterfeit measures for ensuring access of safe medicines to patients, said Mudda.

In a presentation on ‘Market, Compliance and Working with the Regulators’ related to track and trace initiatives by Indian pharma industry, made at NEXUS16 Conference in Boston, USA, Mudda said, “There are several industry initiatives in anti-counterfeiting measures. These include adoption of technologies like overt-covert expertise, forensic methods, serialization , trace and track processes.  

In this regard, the serialization or the track-n-trace technology is considered appropriate for assuring a secure e-pedigree for a drug and medical product enabling its safeguard against imminent duplication. It also provides a comprehensive solution to address identity, authenticity and real-time security of the product.

 Now there are issues in adhering to the Directorate General of Foreign Trade (DGFT) norms primarily because of lack of integration with various Indian packaging machinery leading to an overall line-efficiency drop, he said.

Another challenge is that the Indian pharma industry span from small scale units to multinational companies exporting to over 200 countries. For the trace and track technology, we do see capital investment affordability for small companies for which the estimated cost is US$ 30,000 per line. Technically too with the complex labelling requirements, the paucity of space to introduce bar codes is another issue, he noted.

The key challenges to implement serialization projects for various reasons. With over 15,000 pharma manufacturers in the country, there are various technical and commercial problems encountered during the implementation of the trace and track technology. Prevalence of low skilled packaging operators, complex primary level implementation of 60,000 formulations produced daily supplying to 800,000 retailers, all stakeholders have to be aligned to provide and use facilities for trace and track technology, said Mudda.
 
The MOH undertook many initiatives to deal with the menace of spurious drugs including the feasibility study for implementation of UID (unique identification) . It was recommended to carry out the implementation in 2 phases starting with a pilot project in phase I for one year followed by extending it to 2000 companies in phase II. The Track &Trace through bar code project would start thereafter also in 2 phases of 2 years each. In the phase III would cover all manufacturers with 6 monthly review of progress that would be followed by an amendment to the D&C Rules for introduction of Bar Codes for authentication and track & trace. Now a draft notification to amend Rule 96 of D&C Rules 1945 was issued on 3rdJune 2015 to introduce bar coding on all packs.

“We are committed to control the menace of spurious drugs and to ensure that safe and effective medicines are provided to patients. India is keen to adopt advanced technologies to drive supply chain integrity of medicines”, concluded Mudda.