On March 06, 2019, the Central Government proposed labeling specifications for import and manufacturing permission of New Drug Formulation under form 45/46 of Schedule A of Drugs and Cosmetics Act, 1940 (the 'Act') shall come into force from April 1st 20191.

Earlier the Central Government via Drugs and Cosmetics (First Amendment) Rules, 2018 has amended the manner of labeling of drugs under Rule 96 of Drugs and Cosmetics Rules, 19452 (the 'Rules'). Which instructed drug manufacturers to label generic name of drug or fixed dose combination drug at least two font size larger than the brand name or the trade name, if any. Further, the implementation of these labeling norms was announced on voluntary basis for a period from September 13th 2018 to March 31st 2019 and mandatory from April 1st 20193. The said labeling norms was applicable on:

  • Schedule F or Schedule F (1) drugs as provided under the Act;
  • drugs included in the Indian Pharmacopoeia (IP) or the official pharmacopoeias and official compendia of drug standards prescribed in Rule 124 of the Rules,
  • drugs included in the National Formulary of India (NFI),
  • other drugs, the international non-proprietary name, if any, published by the World Health Organisation or where an international non-proprietary name is not published, the name descriptive of the true nature or origin of the substance;

However, these norms would not cover the fixed dose combinations of vitamin and other fixed dose combinations containing three or more than three drugs.

Labelling of medicines with a caution or warning

Earlier, the Drugs and Cosmetics (Fifth Amendment) Rules, 2018 notified the voluntarily labeling of high-risk medicines with caution and warning effective from November 1st 2018. The high-risk medicines includes the 'Narcotic analgesics, hypnotics, sedatives, tranquillisers, corticosteroids, hormones, hypoglycemic, antimicrobials, antiepileptics, antidepressants, anticoagulants, anti-cancer drugs and all other drugs falling under Schedules G, H, H1 and Schedule X whether covered or not in the said schedules4. However, the Drugs and Cosmetics (Ninth Amendment) Rules, 2019 has announced this labeling requirements shall be mandatory from April 1st, 20195.

Now, the import and manufacturing permission of drug formulation granted under Form 45/46 also requires Labelling of these formulation with a caution or warning, as applicable, depending on whether the drug is covered under Schedule G or Schedule H or Schedule H1 or Schedule X, as specified in rule 97, in legible black colored font size in a completely red rectangular box.


The labelling changes will not affect the quality, safety and efficacy of drug product. But it is expected to promote the usability of generic drugs to the patients. Whereas, the implementation date of labelling changes will create difficulty for drug manufacturers, as they generally keep one year stock of packing materials in advance, and the products get consumed during peak season ranging from April to September. Hence manufacturers expects some more time to implement this packaging changes to avoid losses.


1. https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDE0Ng

2. http://egazette.nic.in/WriteReadData/2018/183769.pdf

3. https://lexcomply.com/rsjadmin/news/201812195052Notification%20GSR%201161(E)-%20%20Drugs%20and%20Cosmetics%208th%20Amendment%20Rules%202018.pdf

4. http://www.cdsco.nic.in/writereaddata/gsr408.pdf

5. http://www.egazette.nic.in/WriteReadData/2019/200553.pdf

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.