Lok Sabha Question No. 2627 (UNSTARRED), answered on 2016-08-02
Subject: Bar Coding of Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: KURUPPASSERY VARKEY THOMAS, KONDA VISHWESHWAR REDDY, VINOD KUMAR BOIANAPALLI

## Government of India Ministry of Chemicals & Fertilizers Department of Pharmaceuticals

## LOK SABHA

## UNSTARRED QUESTION No. 2627

## TO BE ANSWERED ON THE August; 2016 2nd

## Bar Coding of Drugs

2627 . PROF. KV. THOMAS: SHRI KONDA VISHWESHWAR REDDY: SHRI B. VINOD KUMAR:

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state

- (a) whether the Government has any proposal for bar coding of drugs;
- (c) the manner in which bar coding is likely to be beneficial in preventing sale of spuriouslsubstandard drugs and over charging of medicines in the country;
- if so, the details and objectives thereof;
- (d) whether the Government recognise the threat to public health arising from asymmetry in codifying drugs between different manufacturers and service providers and if so, the details thereof; and
- (e) to be taken by the Government to tackle the problem of information asymmetry in the manufacture, sale and distribution of drugs without codes?

## ANSWER

## MNISTER STATE IN THE MNISTRY OF ROAD TRANSPORT AND HIGHWAYS; MNISTRY OF SHIPPING AND MINISRY OF CHEMCALS AND FERTIIZERS (SHRIMANSUKHLMANDAVIYA)

- (a) to (e) The Ministry of Health & Family Welfare has issued a draft notification on 03-06-2015 vide GSR 449(E) to amend the Drugs and Cosmetics Rules 1945 to make barcoding of primary, secondary and tertiary level packing mandatory for manufacturers of drug formulation: However, the notification was not finalized keeping in view the reservations expressed by manufacturers including regarding the high cost of bar coding: of the notification is at Annexure. Copy

REGD NQ D

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## EXTRAORDINARY

PART II  Section 3 Sub-section ()

358]

1937

No. 358]

- 1\_

## answered on 2.8.2016

## answered on 2.8.2016

## MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIICATION

New Delhi, dated the 3rd June, 2015

GSR 449(E) -\_Whereas, the Central Government is of opinion that it is necessary to authenticate the genuineness of drugs and for this purpose, it has been proposed to amend the Drugs and Cosmetics 1945;

And  Whereas, the Central  Govemment has consulted the Drugs Technical Advisory Board for carrying out the amendments in the said rules;

!he Centrel Government proposes to make in exercise of the powers conferred by section 12 and section 33 ofthe Drugs and Cosmetics Act; 1940 (23 of 1940),is hereby published as required under sections 12 and 33 of the said Act; for the information of all persons likely to be affected thereby and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a of forty-five days from the date on which the copies of the Gazette of India containing these draft rules are made available to the public; Drugs = period person interested in making any objection or suggestion on the proposed draft rules may do so in writing for consideration of the Centrai Government within the period so specified to the Under Secretary Any

## DRAFT RULES

- (I) These rules may be called the Drugs and Cosmetics (Fifth Amendment) Rules, 2015.
- (2) shall come into force after the expiry of 180 days from the date of the publication of the final rules in the Gazette of India They
- 2 In the Drugs and Cosmetics Rules, 1945, in mule 96, in sub-rule (1) after clause (xii) the following clause shall be inserted; namely: -

"(xiii) (A) The manufacturers of formulations shall the details specified below to facilitate tracking and tracing of their productprint drug

- (b) at secondary level packaging of one or two dimensional barcode encoding unique and universal global product identification code in the 14 digits Global Trade Item Number format along with batch number, expiry date and a serial number of the secondary pack; unique
- (a) at primary level packaging of two dimensional barcode encoding unique and universal global product identification code in the 14 digits Global Trade Item Number   format with batch number, expiry date and unique serial number of the primary pack; along
- (c) at tertiary level packaging of one dimensional barcode encoding and universal global product identification code in the 14 digits Global Trade Item Number  format  along with  batch  number, expiry dale and serial number of the tertiary unique unique pack:
- (B) The manufacturer of formulation   shall  maintain the data in the parent child drug
- (C) The data referred to in sub-clause (B) shall be uploaded o the central of the Central Government by the manufacturer or its designated agency before release of the drugs for sale or distribution portal

3

## Annexure to Lok Sabha Unstarred Question No2627 to be answered on 2.8.2016

THE GAZETTE OF INDIA EXTRAORDINARY

(D) The responsibility of the correctness, completeness and timely uploading of data on the Central shall be that of the manufacturer: portal

Provided that the provision of this sub-rule shall not be applicable to such formulation which is manufactured for export purpose and where the Government of the importing country has mandated a specific requirement and the exporter intends to aveil the of printing the bar codes in the format specified by the importing country with the permission of licensing authority appointed under rule 21: drug option

Provided further that the tertiary level of the packaging shall have an additional printing of barcode as per sub-clause (A) in addition to any other requirement by thc importing country:

Explanation ~ For the purposes of this clause,

- (b)   secondary packaging level means the carton containing multiple primary packs including a mono carton; and
- (a) primary packaging level means the package which is in physical contact with the drug;
- (c)   tertiary packaging level means & shipper containing multiple secondary pecks as per guidelines issued for data requirement; by the Central Goverment;
- (a) relationship hetween tertiary and secondary packs is the pack aS thc pateui &ld secundary is the chiid; and tertiary pack
- (i)   parent-child relationship between tertiary, secondary and primary packaging levels means-
- (b)   relationship between secondary and primary packs is the secondary the parent and primary as the child: pack

[F. No. 02MMisc /2010-DCIFQC]

Note: The principal rules were published in the Gazette of India vide notification No F 28-10/45-H dated the 21s December, 1945 and last amended vide notification number GSR 390(E), dated the 18th 2015. (1) May,