To                                                                                                                                    May 31, 2021
The Director
Health and OTC Products Division
The Drug Regulatory Authority of Pakistan
Islamabad

Sub: Request for information under Article 19A of the Constitution of Pakistan

Dear Sir,

THE Health and OTC Products Division of the Drug Regulatory Authority of Pakistan will complete its seventh year of existence in June, 2021.

It seems pertinent to see, how it has performed over these past seven years and whether it has served the purpose for which it was set up in 2014?

In order to do a fair assessment of the performance of the HOTC Division, I would need information with regard to the following questions:

1. Has the standard of homeopathic medicinal products (HMPs) improved since the setting-up of the HOTC Products Division in 2014?

2. Does the DRAP have the capacity and expertise to evaluate HMPs in accordance with the requirements of homeopathic drug manufacturing protocols?

3. Do the HOTC officials have requisite knowledge of homeopathic medicine manufacturing protocols and procedures?

4. What steps has the HOTC Division taken since its inception to modify and adapt its evaluation procedure of HMPs to the particular requirements and special characteristics of homoeopathic manufacturing process in accordance with the WHO recommendations?

5. Do the HOTC officials follow the stated policy of the DRAP in respect of the alternative medicinal products? (According to the DRAP policy, the alternative medicines included in the pharmacopoeias adopted vide alternative medicines and health product enlistment rules 2014, are exempt from detailed scrutiny and will be registered on the provision of a registration certificate with the health authority concerned of the country of origin.)

6. Are the meetings of the Enlistment Evaluation Committee held regularly and their minutes published timely?

I will be looking for answers to these and many more questions for a sequel to my earlier write-up: Health and OTC Products Division – an unnecessary burden on the national exchequer?

You are requested to kindly provide me with information regarding the above six points. This information is solicited under Article 19-A of the Constitution of Pakistan.

In addition, it will be a favour if you could also provide the following information:

The number of applications received from June 2014 to December 2020
The number of products approved from June 2014 to December 2020
The number of products rejected during the above period
The number of pending applications

I have chosen this unusual mode of communication because under normal modes, requests remain unattended.

Thanking you in anticipation,

Ahmad Fakir Muhammad, Homoeopath
25/G, National Medicine Market/National Chambers
Aram Bagh Road
Karachi-74200
Pakistan
+923452727303
ahmadfakir@gmail.com
@ahmadfakir