Track and trace codes For Pharma APIs: Ministry issues gazette, CDSCO issues notice

New Delhi: To ensure authenticity, every Active Pharmaceutical Ingredient (API) manufactured or imported in the country will soon bear Quick Response code on its label at every level of packaging. The information will be readable with a software application to facilitate tracking and tracing.

Confirmation to this effect was given by the apex drug regulatory body, Central Drugs Standard Control Organisation (CDSCO) after a gazette notification was published on August 9 2019.

Medical Dialogues had earlier reported that Drugs Technical Advisory Board (DTAB), functional under the Central Drugs and Standard (CDSCO) had recommended “making it mandatory to have quick response code (QR) coding on labels of Active Pharmaceutical Ingredient (API), the most important constituent of any drug formulation for tracing the origin and movement of APIs from manufacturers to formulators through a system of networking.’’

Also Read: Mandatory QR coding for APIs soon: DTAB

With the recent Gazette notification issued by the Health Ministry, it will become mandatory for API manufacturers to include codes to track-and-trace key ingredients used to make medicines in India.

In order to incorporate the same, the Drugs and Cosmetics Rules, 1945 shall be amended by the government in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and in consultation with the Drugs Technical Advisory Board.

The draft rules formulated in this regard published on the CDSCO website reads;

In the Drugs and Cosmetics Rules, 1945, in rule 96, after sub-rule (4), following sub-rule shall be inserted, namely:-

“(5) Every active pharmaceutical ingredient (bulk drug) manufactured or imported in India shall bear Quick Response code on its label at each level packaging that store data or information readable with software application to facilitate tracking and tracing. The stored data or information shall include the following minimum particulars, namely:-
(i) Unique product identification code,
(ii) Name of the API,
(iii) Brand name (if any),
(iv) Name and address of the manufacturer,
(v) Batch no.,
(vi) Batch size,
(vii) Date of manufacturing,
(viii) Date of expiry or retesting,
(ix) Serial shipping container code,
(x) Manufacturing licence no. or import licence no.
(xi) Special storage conditions required (if any).”.

Objections and suggestions from the stakeholders regarding the amendment have been invited wherein the said draft rules shall be taken into consideration on or after the expiry of a period of thirty days from August 9 2019.

Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi - 110011 or emailed at drugsdiv-mohfw@gov.in.

Also Read: 22-member Committee Constituted to guide CDSCO on Medical Device Regulation