Kerala State
Pharmacy Council

A STATUTORY BODY CONSTITUTED UNDER SECTION 19 OF
PHARMACY ACT 1948 (CENTRAL ACT)

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President's Message

B. Rajan - KSPC President

URGENT MOVE FOR AMENDMENT OF THE SECTION 42

It is high time for the amendment of Section 42 of Pharmacy Act. Even though the aim of the Act is to restrict all activities like preparation, compounding mixing and dispensing of medicines on a prescription of a medical practitioner from other than those who have attained pharmacy education. The standards of Pharmacy Education and Pharmacy Councils were also specified by the Act. In olden days all such activities were practiced by Pharmacist himself. But now the scenario has been changed and large scale manufacturing are taking place and the final product ‘medicine’ is coming out from factories. So the Pharmacist could only dispense these medicines to the patients and all the other activities mentioned in the act are away from Pharmacists. .So this is the right time to bring all the activities to the Pharmacy Professionals since a large number of professionals are coming out from huge number of Pharmacy Colleges every year

In 1976 an amendment has brought and on after that date the state Govt. may by notification in the official Gazette appoint in this behalf no person other than a registered pharmacist shall compound prepare, mix or dispense any medicines on the prescription of a Medical Practitioner (It shall not apply to the dispensing by Medical Practitioner for his own Patients). It also state that if no such date is appointed by the Govt. of a state, this section shall take effect in that state on the expiry of a period of eight years from the commencement of the Pharmacy Amendment Act 1976. So from 1st September 1984, this Act came in existence in all other states of our nation. In our state the Govt.have already framed the rules in the year of 1961 and the act is in force from 1st September 1976 itself.

In the Act the section 42 prevents only DISPENSING by unregistered persons and for the contravenes the provision shall punishable with imprisonment for a term which may extend to six months or with fine. This section not clearly mentioning other areas like research , manufacturing,Analisis, distribution and clinical trials of medicines So first time in India our State Pharmacy Council initiated by resolving to PCI for the amendment of this section by incorporating all other areas.

Considering the increase in number of Pharmacy Graduates, Postgraduates and Pharm’D holders we are forced to recommend to the PCI for an urgent amendment for including all the areas of pharmacy profession by replacing the word “Dispensing” in the first part of section 42 of pharmacy Act 1948. An average of 2300 persons were registering every year in the State Council for practicing pharmacy and a total number of more than 48000 Pharmacists have registered with the council up to December 2013. During independence and at the time of the Act came into force, there was only 4 pharmacy colleges were available in India and persons having pharmacy education is very few. So the profession has to manage with other graduates. Now there are sufficient persons with pharmacy education (more than 1700 Pharmacycolleges all over India) and now we are on our own legs and it is high time to reserve all the jobs in pharmaceutical care like research, manufacture, analysis, distribution and clinical trials to persons with pharmacy education.D’Pharm, B’Pharm, PG and Pharm’D are such specialized education and training in pharmacy.

Even though 60 years from the inception of the Pharmacy Act the standards of Indian scenario especially in Community and Hospital Pharmacy not at all achieved the goals or not even comparable with the global standards. That is the one reason for thinking about starting a new pharmacy course by the Pharmacy Council of India which is the Doctor in Pharmacy Course (Pharm’D). It is the patient oriented (bed side)study for 6 years (5+1) and they can be utilized for the community and hospital pharmacy to compete with the global standards. The clinical pharmacy concept which is accepted by the WHO and implemented in all developed and developing nations for the benefit of the patient community and also for the benefit of medical practitioners (Physicians & Surgeons). They are well versed with Pharmacotheraputics,Biostatistics ClinicalPharmacy,ClinicalToxicology,Pharmacoepidemiology,ClinicalResearch, Pharmaco-kinetics, Pharmaco-dynamic, Pharmaco-vigilance and Pharmaco-economics. So they are the actual efficient persons for conducting clinical trials also.

Even now the drug controller authorities are searching in the dark. They are not accepting the Pharmacy Act, which came into force on 1948 and several amendments taken place during 1953 and 1976. The D&C Act came into force on 1940 and the rules in 1945. In that act it states that drugs should be imported, manufactured, distributed, sold and dispensed by the direct supervision of the Registered Pharmacist and after years in 1948 The Pharmacy Act which gave clear definition for Registered Pharmacists came into force. It is the controversy that they are not accepting or considering the Act even now. Even though there is a standing direction from the Hon’ble Supreme Court, the latest Act nullifies the previous Acts. They have submitted statement of facts to the Govt. and also Hon’ble High Court in that sense even now. They are also permitting persons without prescribed qualification or registration with the State Council to practice pharmacy by way of renewal of old Drug License and permitting persons for sale of drugs. This practice should be stopped only by the strong intervention of Govt.

In this context some immediate steps has to be taken by Govt. since Govt. have given NOC to start Pharm’D courses in 10 colleges in our state and the students will pass out during 2014. So state Govt. has the right to protect the constitutional rights of the students. So Govt. should take the matter seriously and immediate action has to start clinical pharmacy in major hospitals in order to protect the Pharm’D holders otherwise they have the only chance to go abroad for getting jobs. The absorption is not only for the student’s sake but also for the sake of our patient community.

It is not so easier to full fill the above rights immediately by the Govt. or any constitutional bodies. So all the organizations in the field of Pharmacy profession has to take part their own strong interventions individually and a united movement by all for the eye opening of officials. I hope all the organizations of this profession will interfere in this matter seriously and come forward for a better tomorrow.


B. RAJAN
President