Indian pharma companies are of the view that they will have no issues to comply with the European Medicines Agency and the European Commission’s new track-and-trace safety requirements which has mandated a deadline for April 2019.

The EMA and EU published new track-and-trace safety requirements. The rule, which takes effect in February 2019, mandates that manufacturers include a bar code which is a unique identification encryption to stall anti-tampering process of medicine packaging.

The USFDA too has beefed up its surveillance on counterfeit, contaminated, and banned drugs, via a guidance on Drug Supply Security Act of 2013. Its track-and-trace norms will be enforced in phases beginning from 2017.

According to Kaushik Desai, general secretary, Indian Pharmaceutical Association, such advance information is most welcome to avoid issues at a later date. Our companies have already started efforts in the direction of track and trace technology.

The government of India has already mandated the use of trace and track for all exports of drugs and have made it mandatory from April 1, 2016 for large companies and April 1, 2017 for the small and medium enterprises (SMEs). Unfortunately the high cost of equipment and increased operational cost have made it tough for companies specially SMEs. However if this now becomes mandatory by the EU, companies will need to adhere stringently, Sunil Attavar, president, Karnataka Drugs and Pharmaceutical Manufacturers Association.

Asserting that it is helpful that the industry has time till 2019, Attavar said that this will give sufficient time for companies to be ready and we too should also align to this timeline for all exports.

In the meantime SME’s must be supported with funds to purchase the required equipment and also to train personnel. To make it easier for companies to adapt, pharma associations should be empowered to pass on these benefits to members, pointed out Attavar.

The new regulation also stipulates interim compliance guidance for drug companies with existing or new marketing applications in the region. The EU is now strengthening regulatory compliances to ensure highest quality product enters its region. In 2011, the EU issued the Falsified Medicines directive. Earlier in 2002, it has issued standards for child resistant packs. Even the USFDA in 2001.

The track-and-trace compliance is seen to be capital intensive exercise for pharma manufacturers because dealing with specific requirements, implementation of bar codes and installing anti-tampering devices are a significant investments especially for the SMEs.

Commenting on the feasibility for SMEs, Archana Dubey Mitra, vice president, international marketing, Bal Pharma said that a lot of efforts and investment would be required to implement the system. However once implemented this will provide consumers quality medication safeguarding health. “We appreciate a well planned approach towards safety and efficacy of medicines. We should also work on parallel mechanisms to safeguard industry for commercial viability, she added.