Track & Trace for Pharmaceutical Products compliance

Background: Following the recommendation of the drugs technical advisory board, the national drug regulatory body is getting ready to introduce a tracking mechanism and has identified 300 top brands for the purpose on the basis of moving annual total data. The plan, to be implemented on a voluntary basis, is to print a 14-digit number on the labels of the top 300 pharmaceutical brands along with a mobile number of the manufacturer. A consumer can easily check the genuineness and quality of a drug by sending a text message to the given number and getting details of the manufacturer, batch number, or expiry date. The regulator will hold a meeting with manufacturers’ representatives on June 25, 2022, to discuss modalities.

 What we lack is effective supply chain management. A drug manufactured at a plant in Uttarakhand travels by road or rail and reaches the other corner of the country in ordinary temperature. Storage facilities at lorry godowns are also poor. Unless we rectify these issues, nothing will change on the ground. They call it a ‘track and trace’ mechanism, but it is not. You can’t find out how the drug travels and reaches the consumer.

The commerce ministry has recently extended the deadline to implement the “track and trace” or bar-coding system for the export of drug formulations to November 15 this year citing technical issues. The initiative aims to maintain the “parent-child relationship in packaging levels and its uploading on the central portal”. The Pharmaceuticals Export Promotion Council highlighted the problems faced by exporters to the government. The council had pointed out that the non-compliance of stipulation with regard to bar-coding on secondary and tertiary packing as well as uploading of the data on the portal had resulted in the exporters facing problems at Customs.

  1. Compliance under Drugs & Cosmetics Rule 1945:
  2. DCGI vide dated 7th March 2016 issued a public notice addressing the Director General Foreign Trade on the implementation of track and trace of pharmaceutical products for export purposes.
  3. CDSCO notified the Drugs (Eighth Amendment) Rules, 2022. They shall come into force on the 1st day of August 2023.
  4. Rule 96, after sub-rule (5) and before the explanation, the following sub-rules are inserted, namely: —

(6) The manufacturers of drug formulation products, as specified in Schedule H2, shall print or affix a Bar Code or Quick Response Code on its primary packaging label or, in case of inadequate space in the primary package label, on the secondary package label that stores data or information legible with a software application to facilitate authentication.

 (7) The stored data or information referred to in sub-rule (6) shall include the following particulars, namely: — (i) unique product identification code.

(ii) proper and generic name of the drug; brand name.

(iv) name and address of the manufacturer.

 (v) batch number.

(vi) date of manufacturing.

 (vii) date of expiry; and

(viii) manufacturing license number.

  1. Further, In the said rules, after Schedule H1, the following Schedule shall be inserted, namely SCHEDULE H2 which contains a list of Brand names of 300 drug formulations. Please find enclosed a list of brand names of the formulation for your reference.
  2. The task force on the track and Trace mechanism recommended the following guidelines:
  3. The members felt that a beginning has to be made in this direction and gradually all the stakeholders have to be convinced, educated, and gradually made to follow the system. It was also deliberated and decided that labelling provision under Rule 96 of Drugs and Cosmetics Rules has to be suitably amended to include track and trace.
  4. Going through the meetings with various stakeholders, the Task Force finally concluded that Track and Trace to be effective, the following:
  5. Two systems shall be implemented simultaneously.
    1. Unique Identification Number for each primary pack for identification of the drug by a consumer.
    2. 2-D Bar Coding with all details of a product incorporated in it for easy retrieval Legal Implications: –
  • Anything printed on the label which is not mentioned in Rule 96 of Drugs and Cosmetics Rules, and which will be used by the regulators in its day-to-day functioning has to be mandated by law.
  1. Requirements to be implemented by the manufacturers, in due course of time. Of data from any point in the supply chain.
  2. Cost of the project

The cost of the project cannot be ascertained at this stage as there is a number of variables relating to software, hardware, other consumables, the volume of business, etc. Wide variations have been noticed in the pricing of hardware/software, etc. to be used in the project. The exact pricing structure can be arrived at only after a decision is taken about the final technology solution to be implemented for the purpose. Hence, after receipt of this report the NIC which is the sole technology service provider for the Govt. may be directed to prepare a Detailed Project Report (DPR). Following submission of the DPR cost estimate for implementation of the project can be arrived at. The cost of the project would also include the cost of conducting training and aware Implementation of the project.

  1. The task force members extensively deliberated on the mechanism and the time frame for implementation of the scheme. A tentative roadmap that can be followed is as follows:
  1. The first requirement is for NIC to prepare a feasibility study based on the above points. The basic details of the requirements that the NIC will have to work on are mentioned above and the NIC will provide as early as possible.
  2. The NIC will guide on the requirement of hardware for the successful implementation of the scheme.
  3. It is estimated that about 2 lakh SMS per day will have to be verified by the system initially. This will be after the extensiveness of the consumer and the industry.
  4. It is decided to implement UID and track & trace for drugs in 3 phases which are as follows:
  • Authentication by SMS through UID (either alphanumeric or non-cloneable):
  • Phase I:
  1. The members decided to proceed on this system by doing a pilot project initially which may be for a period of 1 year. Following the pilot project, the feasibility of the scheme will be examined, and necessary changes made.
  2. Approximately 200 products would be identified during the pilot project from the fast-moving category of drugs in the market by the CDSCO in consultation with major states. The drugs can be selected by doing a market survey and also obtaining necessary market research data.
  • The products may include drugs of both large and SMEs.
  • Phase II:
  1. Phase II would be a period of approximately 2 years.
  2. Phase II would commence after the successful completion of Phase I and the data obtained from Phase I is examined and necessary changes made in the scheme.

iii. Approximately 2000 companies would be included in Phase II

. In this Phase, all the products of the selected companies will be included.

  1. About 50% of the selected firms will carry out barcoding also for their primary packages in this Phase.
  2. A further evaluation of the scheme would be done after the completion of Phase II and if required, necessary changes will be made.

vii. Evaluation of the success of barcoding in the primary packages would be examined in detail and suitable amendments made in case of very small primary packages.

  • Phase III:
  1. In Phase III all manufacturers in the country will be included.
  2. Every 6 months the progress of implementation of the scheme in the country would be examined and minor changes made if and when required. Track & Trace through Bar Code etc.: This scheme will start 6 months after the commencement of Phase II of the UID scheme.

Conclusion: The primary liability of the track and trace mechanism via barcode is of the manufacturer, however, due to the amendment in the Drugs and Cosmetics Act, 1940 and Rules marketing companies are equally liable for regulatory compliance including Rule 96 on labeling of drugs. Pillup as distributor or retailer is responsible to the extent that it does not sell or distribute any drugs which are not labelled as per Rule 96 and do not sell any spurious or fake, falsified medicine.