Showing posts with label OTC drugs. Show all posts
Showing posts with label OTC drugs. Show all posts

Wednesday, July 17, 2019

DELHI HIGH COURT ORDER ON 2 PILS OF HEART CARE FOUNDATION OF INDIA (HCFI) ON ISSUES OF PUBLIC HEALTH IMPORTANCE




Dr K K Aggarwal and advocate Ira Gupta

On 3rd of this month, the Hon’ble Chief Justice of Delhi High Court had strictly directed Central Government to provide the list of Over the Counter (OTC) Drugs by September 12 in the PIL filed by Heart Care Foundation of India. The Hon’ble High Court passed the following order:

“If the report as per the directions of this Court is not filed so far, the same be filed on or before the next date of hearing. We also direct the respondents to provide a list of Over the Counter (OTC) drugs by the next date of hearing.”

We appeared personally and argued and informed the Hon’ble Court that currently no such list is available by the government and the chemists and pharmacists are dispensing the schedule drugs on the plea that they do not have a list of OTC drugs where medical prescription is not required. The Central Government has filed its counter affidavit in which the Government had stated that it has constituted committee for the formulation of law on OTC drugs, however, the minutes of the meetings conducted by the sub-committee are under preparation.



In another case, the Hon’ble Chief Justice of Delhi High Court directed India Railways, Delhi Metro, all courts in Delhi to file their status report in the PIL about the installation of cardiopulmonary resuscitation (CPR) and automated external defibrillator (AED) machine in public places like courts, railways and metro.

The Hon’ble Court has passed following order:
“We have heard Dr.K.K.Aggarwal at length and also learned counsel for the parties. Learned counsel for the respondents to file an affidavit by the next date of hearing, stating clearly the following:-
(a) What steps they have already taken to establish the centres giving Basic Cardiac Life Support (BCLS) as well as the Advanced Cardiac Life Support (ACLS)?
(b) What is the infrastructure which is already provided and what infrastructure they are going to provide in the new centres?
(c) How many personnel have been deployed at such centres and what is the future road map for the personnel which are to be engaged in such centres which are yet to be established.
(d) In the affidavit it shall also be highlighted about the training given to the persons who are going to be deployed at the aforesaid centres.
(e) The respondents shall also highlight about the availability of ambulances with National Ambulance Code : Automotive Industry Standard (AIS) – 125 Part-II facilities.”

These directions of the High Court were in direct response to the PILs filed by HCFI, which has been named amicus curiae in both the cases.

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA

Sunday, February 24, 2019

DCC deliberates on defining and regulating OTC drugs




Excerpts from the Minutes of the 55th Meeting of the Drugs Consultative Committee held on 31.01.2019 and 01.02.2019 at New Delhi

“Agenda No. 8: Consideration of the report submitted by Sub-Committee of Drugs Consultative Committee (DCC) on over-the-counter (OTC) drugs

DCC was apprised that a sub-committee was constituted in 52nd meeting held on 18.09.2017 under the chairmanship of Dr. Ravi Shankar IPS, Director General, DCA, Andhra Pradesh to examine comprehensively the drugs marketed in country vis-à-vis conditions for sale stipulated under various schedules, namely H, H1, G, X, K and recommend the list of drugs which may be considered for marketing as OTC along with conditions to be followed.

The sub-committee examined the matter in detail and submitted its report. The sub-committee has given recommendations on the following aspects on OTC drugs.

1.     Definition of OTC drug
2.     Basic Characteristics of OTC drugs
3.     Classification of OTC drugs
4.     Preparation of Initial list of OTC Drugs
5.     Regulation of Rx Drug to OTC Drug Switch Process
6.     Regulation of new OTC drug approval
7.     Manufacturing and labelling of OTC drugs
8.     Distribution and sale of OTC drugs
9.     Advertisement of OTC drugs
10.  Pricing
11.  Miscellaneous

DCC opined that detailed examination of the report submitted by subcommittee is required to take further action in this regard. Therefore, DCC constituted a subcommittee under chairmanship of Shri. N.K. Ahooja, Drugs Controller, Haryana to examine the report on Over-The-Counter (OTC) drugs.

Composition of sub-committee:

1.     Shri. N.K. Ahooja, (Chairman), Drugs Controller, Haryana
2.     Shri. Amaresh Tumbagi, (Member), Drugs Controller, Karnataka
3.     Shri. R. Chandrashekhar, (Convener) , DDC (I), CDSCO (HQ)

The sub-committee shall examine the report and submit their recommendations to DCC for further consideration.”

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA