India Regulatory Updates

This is a compilation of the recent regulatory updates for India. Every week, we post an update of what's new, which you can view here.

2019

• August 11: The Ministry of Electronics and Information Technology has drafted and circulated a new technical design for an export track and trace system, which has been proposed to replace the existing Drugs Authentication and Verification Application (DAVA) portal. The proposed design uses a proprietary product coding and reporting scheme that does not align with global interoperability standards such as those developed by GS1.
• July 21: A public notice was released stating that aggregation and reporting have been further postponed until April 1, 2020.
• July 14: A public notice has circulated announcing that aggregation and reporting have been postponed until April 1, 20
• June 16: The government has appointed a new expert committee to improve the existing serialization and traceability efforts for exported medicines and to accelerate the adoption of similar requirements for domestic medicines.
• February 3: The government has published a new circular that postpones the implementation of primary-level pack barcoding for government procurement until April 2020.
• January 27: The government published new barcoding requirements for primary pack-level identification (no serialization) to go into effect April 1, 2019. These requirements will affect government-tendered products in the domestic market. The industry has pushed back on the timelines.

2018

• November 4: The implementation of aggregation and reporting requirements to the DAVA portal has been postponed until July 1, 2019. The scope of the requirements remains the same, but there is expected to be modifications to the overall data model and potentially some of the reporting requirements.
• October 7: A government sponsored workshop was held on October 5 to discuss export requirements and the patient scanning initiative.
• September 2: DAVA is still planning to bring their portal back online in November, but they haven't provided insights as to the technical/data changes for the update. At the same time, there's no word on when the industry will be apprised of the changes to allow serialization/reporting systems to be updated.
• July 15: The relaunch of the DAVA portal has an 11/15 deadline. A meeting was held in New Delhi on 6/26 to discuss domestic medicine identification. At this meeting, verification was just the starting point as the government was openly asking for other options besides the on-pack identifier.
• June 22: DTAB is holding a meeting on 6/25 to discuss the proposed government approach to apply human readable serialization codes on the top 300 brands for domestic circulation.
• May 26: The official DGFT notice of the six-month hiatus for DAVA reporting was published.
• May 13: An official notification was published that put a six-month pause on India DAVA compliance reporting as DGFT works with the DAVA team to update and fix issues that are causing shipments to be held up at customs.
• April 29: An update was issued to last week's India note on DGFT publication of a letter outlining India's intention to enforce current serialization and reporting requirements.
• April 21: DGFT published a letter outlining India's intention to enforce current serialization and reporting requirements. This letter came about after several reports came in from the field of pharmaceutical company product being stopped in Customs due to product not being serialized or not having the correct DAVA system data.