Sch K amendment - Has these Objectives been Achieved?
The amendments to Schedule K of the Drugs and Cosmetics Rules, 1945, introduced significant changes to streamline drug regulations and accessibility. Here’s a comparative summary of the situation before and after the amendment:
👉Before the Amendment
1. Applicability and Scope:
Schedule K exempted certain classes of drugs and circumstances from specific provisions of the Drugs and Cosmetics Act, such as licensing requirements.
Focused primarily on traditional practices like home remedies, medicines for medical professionals' personal use, and drugs distributed under government programs.
2. Community Pharmacist Role:
Limited emphasis on the active role of community pharmacists in drug dispensing.
Drugs like antimalarials, contraceptives, and certain public health program-related medications were exempt from licensing under specific distribution schemes.
3. Challenges:
Regulatory gaps led to potential misuse and lack of uniformity in drug dispensing.
Limited coverage for modern healthcare needs.
The evolving role of pharmacists was not well-integrated.
👉After the Amendment
1. Expanded Scope and Clarity:
The amended Schedule K included clearer definitions and expanded exemptions to include new healthcare settings, such as telemedicine, e-pharmacies, or alternative delivery mechanisms.
Streamlined processes for government health programs.
2. Enhanced Role of Pharmacists:
Stronger emphasis on the role of qualified pharmacists in dispensing drugs exempted under Schedule K.
More robust inclusion of community pharmacists to bridge healthcare access gaps.
3. Strengthened Public Health Initiatives:
👉Better alignment with national health priorities, including immunization, TB control, and other public health programs.
Rationalized exemptions for drugs used in specific national healthcare programs, reducing regulatory delays.
4. Digital and Telemedicine Integration:
Eased rules for modern dispensing methods, recognizing the role of digital healthcare and online pharmacies in delivering medicines, especially in remote areas.
5. Regulatory Compliance:
👉Tighter monitoring of exempted drug categories to reduce misuse or diversion.
Improved documentation and accountability measures.
👉Impact of the Amendment
Improved Accessibility: Rural and underserved regions benefited from greater accessibility to essential medicines without unnecessary bureaucratic hurdles.
Pharmacist Empowerment: Elevated pharmacists’ status as critical stakeholders in ensuring safe drug delivery and patient counseling.
Adaptation to Modern Healthcare Needs: Regulatory provisions evolved to accommodate digital healthcare platforms, telemedicine, and innovations in drug distribution.
These changes have harmonized regulations with the dynamic healthcare landscape while ensuring public safety and enhancing pharmacists' contributions to patient care.
Has this not made 'Pharmacist' dispensable/Replaceable and Substitutable?
PCI has a right to verify and demand reversal if it is found curtailing the scope of the profession and professionals
POV : Bhagwan PS
The "Schedule K of the D&C Act," 1948, which allows the Indian Doctor to dispense ,Sell Medicine without any Drug Licence .... Which is a Criminal offence in All the countries of the world... In older times when there were not enough Pharmacy/ Chemist shop, and the shops closed at 8 pm... the Doctors and Clinics who needed Medicine in case of emergencies were allowed to keep emergency medicine for patients, and a amendment was made in the D&C act... Called the Schedule k... Which allows the Indian Doctor to keep Medicine at his clinic/ nursing home... without any Drug Licence... But now with availability of 24 hrs Pharmacy/ Chemist shop... This rule should have been abolished as elsewhere in rest of the world... Where a Doctor cannot keep/ sell even a paracetamol from his Clinic/ nursing home.... But in India, since the Pharma lobby is controlled by the IMA... This law has not been changed... And this is the reason which even a Quack can be allowed to keep Medicine in his clinic and dispensing and loose Medicine are allowed in India... The IMA is to blame for mushrooming of the Quacks and even the misuse of Schedule k, of the D&C Act, 1948 by The Nursing Homes, Clinic and Hospital ... Leaving the pharmacist to just use the "Pharmacist License" to Open a Chemist/ Pharmacy shop ....A Pharmacist who is an expert in Medicine/ Drug in India , is left just with a work to pass on the Medicine to the patient as a salesman... While in rest of the world, a Patient looks forward to getting expert advice by a Clinical Pharmacist on the correct dosage and per kg body wt. Calculated exact dosage schedule ( in case of Critical medicines), precautions, monitoring and reporting any side effects, adverse effects of a Drug prescribed by a Doctor. Across the world, No person except the Pharmacist can dispense, sell or guide anyone on the Medicine/ Drug.
