Final thoughts about the iVEDA deadline and requirements

We will of course continue to monitor these regulations and post news when necessary. Bookmark our blog and check back often to make sure you’re keeping up to date. And contact us today if you have any questions about this delay or compliance in any other country where you do you business.

For a good overview of India’s pharma regulations, read our update from September 2022. If we may say, our “Final thoughts” section in that article was prescient. We wrote that “India’s track and trace requirements are obviously evolving” and the pharma industry should “expect more changes as the deadlines for APIs [active pharmaceutical ingredients], iVEDA reporting, and barcoding get nearer.”

That post also cited some statistics from India’s Department of Pharmaceuticals’ 2020-21 Annual Report. Check those out and compare them with the highlights from the 2021-2022 Annual Report below. India remains one of largest and most important pharma markets in the world — and we can help ensure you stay compliant as its regulations evolve.

India pharma stats, 2021-2022

• India provides generic medicines to more than 200 countries.
• India is home to 8 of the world’s 20 largest manufacturers of generic medicines.
• More than 55 percent of its pharma exports to go to “highly regulated markets.”
• Ninety percent of World Health Organization (WHO) pre-qualified APIs are sourced from India.
• Sixty-five to 70 percent of the WHO’s vaccine requirements are sourced from India.
• As of August 2021, there were 741 U.S. FDA-compliant manufacturing sites in India.
• As of December 2020, Indian companies had secured nearly 4,400 abbreviated new drug application (ANDA) market authorizations.

In recent weeks, India has made major changes to its exporting policies, launched its new iVEDA portal, and postponed pharmaceutical regulations. The timing — in the midst of the COVID-19 pandemic and a 21-day lockdown of the country’s 1.3 billion people — raised eyebrows in both industry and government circles. Let’s take a look at what’s been happening.

Restrictions on the export of active pharmaceutical ingredients (APIs) and medicines

India is the world’s primary source of generic drugs, so its announcement last month that it was restricting the export of 13 APIs and 13 associated medicines was unwelcome news in many quarters. Indian drug manufacturers must get government permission to ship any of these APIs or medicines overseas, including:

- Paracetamol (a.k.a. acetaminophen), which is used in Tylenol
- Acyclovir, an antiviral used to treat shingles
- Antibiotics, including neomycin, clindamycin salts (i.e., hydrochloride), tinidazole, metronidazole, and chloramphenicol
- Progesterone, a hormone supplement found in birth control pills
- Vitamins, including B-12

India manufactures at least 20 percent of the world’s generic drugs; the restricted items account for about 10 percent of the country’s pharma exports. According to the FDA, in 2018, 24 percent of medicines and 31 percent of medicine ingredients imported into the United States came from India. The U.S. and Indian governments are currently holding discussions to ease the restrictions.

There has been pushback from India’s pharma sector. For example, it’s been reported that the Pharmaceuticals Export Promotion Council of India (Pharmexcil) wrote India’s Directorate General of Foreign Trade (DGFT) to protest that the restrictions will cause Indian drug companies to lose money and could harm their “credibility and reputation in the international market.”

Generic drug manufacturers in India had talked of shortages if COVID-19 continued in China, the source of many APIs for the Indian market. The Indian government has said the restrictions would be temporary. We will continue monitoring this supply chain story and provide updates when needed. Check back often.

The new national iVEDA portal for drug authentication and track and trace

On April 1, India officially replaced its Drugs Authentication and Verification Application (DAVA) with the Integrated Validation of Exports of Drugs from India and its Authentication (iVEDA). The iVEDA portal is a repository database that will be used for archiving serialized batch data; it’s key objective is not to track and trace India’s drug supply.

Manufacturers and exporters had complained of technical snafus with DAVA, including problems uploading data encoded on the 2D barcodes required on secondary and tertiary drug packaging and maintaining the parent-child relationship of these packaging levels. In response, the Department of Commerce convened a committee to consult with supply chain stakeholders, ultimately deciding to scrap DAVA and create an entirely portal for validation and authentication of drugs for export.

The iVEDA portal was developed by the Centre for Development of Advanced Computing (C-DAC), “the premier R&D organization of the Ministry of Electronics and Information Technology for carrying out R&D in IT, electronics, and associated areas.” Pharmexcil held testing workshops in Mumbai, Ahmedabad, Hyderabad, and Chandigarh on February 10, February 11, March 3, March 5, respectively, to give stakeholders an opportunity to use the portal and give feedback.

Big change to a regulatory deadline

Just before iVEDA launched, India’s Directorate General of Foreign Trade announced a deadline change for the implementation of the track and trace system for drug exports, particularly as it applies to the parent-child relationship of drug packaging.

On March 31, Public Notice No. 66/2015-2020 extended the date for compliance from April 1, 2020, to October 1, ,2020:

The date for implementation of track and trace system for export of drug formulations with respect to maintaining the parent-child relationship in packaging levels and its uploading on central portal has been extended up to October 1 this year.

The extension makes sense given the problems manufacturers and exporters had maintaining the parent-child relationship of secondary and tertiary drug packaging in DAVA and the newness of iVEDA.

The change applies to both small-scale industry (SSI) drugs and non-SSI drugs. Manufacturers and exporters must still print 2D barcodes for different packaging levels (i.e., primary, secondary, and tertiary) and upload the data to iVEDA, but they do not have to maintain the parent-child relationship between secondary and tertiary packaging until October 1. These stakeholders must also have a manufacturer code and product code allotted by GS1 India, though codes from C-DAC will apparently suffice. They are also responsible for the correctness and completeness of data and ensuring its timely upload to iVEDA, but according to some reports may shift this burden to an adjacent supply chain trading partner, such as a wholesaler, distributor, or retailer.

Final thoughts

rfxcel has worked in the Indian pharma market for many years. We understand its complexities, challenges, and benefits. Our signature rfxcel Traceability System (rTS) and rfxcel Compliance Management (rCM) solution have helped our customers keep up with India’s regulations and remain competitive. Contact us today to see how we can maximize your impact in India. And keep an eye on our blog for more information about how COVID-19 is affecting global supply chains. Stay safe!