India: Measures Taken By CDSCO Under D&C Rule To Ensure Quality Of Drugs In The Year 2018

Last Updated: 11 February 2019
Article by Singh & Associates

Central Drugs Standard Control Organization (CDSCO), in coordination with concerned State Licensing Authority for action as per the provisions of Drugs & Cosmetics Act, 1940 (the 'Act'), and the Drugs & Cosmetics Rules, 1945 (the 'Rules'), has taken various measures by way of bringing about certain amendments in the existing regulations, to ensure the quality of drugs including generic drugs manufactured / marketed in the country. In the year 2018, there were a total of ten amendments in the Rules. The brief details of amendments are as under:

1. Printing Drug's Generic Names in Bigger, Bolder Font than Brand Name

On March 13, 2018, the Drugs and Cosmetics (First Amendment) Rules, 2018 notified under Gazette notification no. G.S.R. 222 (E) amended Rule 96 of the Rules. The amended rule now provides that the proper name of the drugs (generic) shall be printed in a conspicuous manner which shall be in the same font but at least two font size larger than the brand name or the trade name, if any1. According to the Drugs and Cosmetics (Eighth Amendment) Rules, 2018, the labelling requirement shall be on a voluntary basis for a period from 13.09.2018 to 31.03.2019 and thereafter shall be mandatory2.

2. Steroidal drugs are included under Schedule H of Drugs and Cosmetics Act, 1940

Vide Gazette notification no. G.S.R. 277(E) dated March 23, 2018 the Drugs and Cosmetics (Second Amendment) Rules, 2018 were notified thereby updating Schedule H provided under the Rules, with addition of 14 Steroidal drugs - Alclometasone, Beclomethasone, Betamethasone, Desonide, Desoximetasone, Dexamethasone, Diflorasone diacetate, Fluocinonide, Fluocinolone acetonide, Halobetasol propionate, Halometasone, Methylprednisone, Prednicarbate, and Triamcinolone acetonide - making them prescription drugs for patient use3.

3. CDSCO mandates the submission of stability data of all drugs before granting product license

On April 10, 2018, the Drugs and Cosmetics (Third Amendment) Rules were notified vide Gazette notification no. G.S.R. 360 (E), 2018, for replacing the words 'patent or proprietary medicines' with the word ' drugs' of rules 71, 71b, 76, 76A, and schedule D of the Rules; which now makes it mandatory to submit stability data etc. for all drugs by applicant as per the provision before grant of product license by the respective State Licensing Authority4.

4. Inclusion of Oxygen 93% supplied from liquid oxygen for production of Oxygen 93% USP under Schedule K

Vide Gazette notification no. G.S.R. 385(E) dated April 19, 2018, the Drugs and Cosmetics (Fourth Amendment) Rules, 2018, amended the Rules, and thereby included under Schedule K, Oxygen 93% supplied from liquid oxygen in the production of Oxygen 93% USP by a hospital or medical institute for their captive consumption, in addition to oxygen being produced from air by the molecular sieve process. Making it under Schedule K provides exemption from the applicability of provisions of Chapter IV (Manufacture, Sale and Distribution of Drugs and Cosmetics) of the Act, and the rules provided that the production facilities shall be open to inspections by an Inspector appointed under the said Act5.

5. Central Government notify labeling specification of Schedules G, H, H1 and Schedule X drugs

On April 26, 2018, the Drugs and Cosmetics (Fifth Amendment) Rules, 2018 notified vide Gazette notification no. G.S.R. 408(E), updated the labeling specification of inner most container of the following categories of drugs and every other covering in which the container is packed shall bear 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 coloured font size in a completely red rectangular box without disturbing other conditions printed on the label under these rules.

The labelling specification applies on 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 schedules6.

6. Extended validity of Drug import license for personal use

On June 01, 2018, the Drugs and Cosmetics (Sixth Amendment) Rules, 2018 notified vide Gazette notification no. G.S.R. 521(E) updated Form 12B, which now allows permit holder to import the medication for personal use till such time as the patient requires the drug as per the prescription of a registered medical practitioner, and the permit holder shall submit details of drugs imported and utilized to the licensing authority on yearly basis, which was for only six month period earlier7.

7. Oxytocin reclassified as Schedule H1

Vide Gazette notification no. G.S.R. 795(E) dated August 21, 2018, the Drugs and Cosmetics (Seventh Amendment) Rules, 2018 reclassified oxytocin from the list of Schedule H drugs to Schedule H1 drug under the Rules, which requires retail chemists to document the customer and physician details for each sale for at least 3 years further to check the indiscriminate use of drug8.

Moreover, the Central Government also announced the strict regulatory control over manufacture, sale and distribution of oxytocin this year to curb its misuse under section 26A of the Act.

8. Clarification in case of use of colors in empty gelatin capsules (Hard and Soft)

On December 07, 2018, the Drugs and Cosmetics (Ninth Amendment) Rules, 2018 notified vide Gazette notification no. G.S.R. 1186(E) amended Rule 127, that in the manufacture of gelatine capsule approved/permitted colours shall be used and drug label containing gelatine capsules need not indicate the name of colour added as more than one colours are quite often used9.

9. Revised regulatory fees for various drug licensing activities

On December 12, 2018, the Drugs and Cosmetics (Tenth Amendment) Rules, 2018 notified vide Gazette notification no. G.S.R. 1193(E) revised regulatory fee and increased the fee for site registration, product approval, licenses for import of drugs and medical devices, permissions for clinical trials and import of drugs for tests and overseas inspections10. Notable, the Central government last updated this fee in 2003.

10. Mandatory unique ID number system to keep a check on misleading advertisement for ASU drugs

On December 21, 2018 the drug and cosmetics (Eleventh amendment) Rules 2018 notified vide gazette notification no. G.S.R. 1230(E) inserted new Rule 170 in Rules, introduced unique ID number system for Ayurvedic, Siddha and Unani (ASU) medications sold in the country, which provide a stringent regulatory check for misleading and inappropriate advertisements. As per the new notification, if the drug is not intended for therapeutic purpose, for instance a health or nutritional supplement, the manufacturer can advertise the product after obtaining a unique identification number (UIN) from state licensing authorities11.













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.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions