Friday, 24 February 2023

Drug and Cosmetic act and Pharmacy Practice Regulations Act

Drug and Cosmetic act 1940 and Pharmacy act 1948 and Pharmacy Practice Regulations Act 2015 all are different and are mismatch. 

KNOW (Y)OUR PHARMACY ACT & ITS WEAKNESS:

1.. The Act was enacted in 1948 to which the States can frame Rules. Rules should be in compliance with and without prejudice to the Act 
Weakness: Not updated to current scenario and needs. States and state councils are working with total disregard to the Act as if it is their own registered association.
2. The Act provides for constitution of Central council and state councils. Since ER is in force there is no provision to form Tribunal for RRegistation.
3. Act provides for elected and nominated and ex-officio Govt official members in the council.
Weakness :
a. Both central and state councils are dominated by traders and academicians.
No reservation to have representation from Industry, Clinical trial, hospital and clinical pharmacists and women.
3. All members except those from Medical council, UGC etc should be Registered pharmacists as per the Act.
Weakness:
Since neither the Govt nor the PCI is supervising the council:
a Many councils including Central council are running with members who are not Reg Ph as per the Act. .
b.There are councils headed, presided over  and administered by non pharmacists.
- How can the resolutions be considrd valid under the Act.
4. There are clear guidelines to convene and conduct meetings.
Central council passes hundreds of resolutions in just 4 to 6 hours- Amazing that Limka and Guinies book of records has not noticed.
Weakness: 
All meetings and deliberations are under mutual understanding, obligation and for self-esteem aggrandizement. 
Real professional interest and professionalism are nowhere seen or felt. There is no one to verify and pull up the violation.
5. The term of office of members is only 5 years.
Weakness:
Elections are delayed due to vested interest on one side and due to deviation in awarding registration.
Most of the times, the voters (reg Ph) do not get information on election schedules.

Voter should send the marked ballot paper by Reg.post a/d only.
Weakness:
a. It was good in 1948. Now it is outdated and has made easy way for the interested contestant to collect personally and mail by reg post on behalf of the Ph. Returning officer sinceerly accepts all ballot papers rceived by rreg post and declardeclares rsult.
Obvious name/s get elected.

Remedy:
Besides the Amendments needed the following measures would help:

All councils should publish on their website all documents:
a. Names of members, Reg.No with State, Validity and Govt nomination Notifications.
2. Meeting calendar for the year.

3. Proceedings of the meetings. Since all decisions except the administrative issues are related to profession publishing the same cannot be refused.
All resolutions should quote the section, clause and Rule No. under which the the decision was taken like, In exercise of the powers conferred under section...., Clause ....., Rule No. ....

4. List of Reg Ph. and List of names removed due to non renewal and names restored.

5.  D&C Act and Pharmacy Act mismatch with each other.:
a. Pharmacy Act and PPR 2015 doesn't mention SALE of drugs. D&c act do not recognize pharmacy practice.
b  Regulatory does not work in support of the council and do not share their inspection report extract with the council

6. The drugs controller should publish the name and address  of the licensee, Name of the approved pharmacist and his registration no. on their website

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