SWOT analysis of Pharmacy Practice Regulations 2015

Tuesday, July 4, 2023

SWOT analysis is in depth a systematic analysis of strength, weakness, opportunity, and threat. In pharmacy, drugs are used to treat diseases and distress. Drugs are safe when used properly under the supervision of healthcare professionals. To avoid harm to the patients, health consumers and patients need the assistance of healthcare professionals. The core healthcare professionals are doctor (to diagnose) nurse (care and drug administration) pharmacists (from manufacturing to dispensing). India is called a world pharmacy as they have emerged as a leader in the manufacturing of A-Z medicines for the whole world. The medicines manufactured in India are exported to highly regulated markets like North America, Europe, and Australia. It is very well established that Indian-manufactured formulations are cost-effective and are manufactured as per the standards of regulatory stipulations. The quality of medicines is acceptable in rich and poor countries alike. Strict discipline is adopted while manufacturing formulations.

Manufacturing of medicines is under the direct control of the Drugs Controller General of India (DCGI). Drugs can cause great harm to the users (patients and health consumers) if no registered pharmacist is engaging in dispensing and counseling the patients and health consumers on safe use of medicines. As per the law, no other person other than a registered pharmacist should not dispense or counsel patients in matters of medicines. It is for desisting common man, indulging in self-medication, and prevention of harm caused by irrational use of medicines.

There seems to be no control over the sale of medicine in the country, anybody can walk into a pharmacy and buy prescription medicine without a prescription. Especially antibiotics’ indiscriminate use has led to highly dangerous and multi-drug-resistant strains of bacteria. This style of selling medicine has caused several issues in the country. The drugs are sold like any consumer goods to the public, which is illegal and does great harm to the health of the public at large. The problem has led to renting a certificate of registration which is a mockery of the Pharmacy Act 1947. Unfortunately, it has led to the loss of the identity of pharmacists and pharmacy retail is controlled by private business owners and family members rather than registered pharmacists. There is nobody to check the contents written in the prescription and explain drugs, dose storage as well usage of medicine dispensed in retail pharmacies. The pharmacy earns profit by the margin on sales and discount on purchases and several trade schemes provided by the manufacturer. Further, the corporate has entered the market by creating an online pharmacy to capture the market by luring with attractive trade discounts directly to the patients and health consumers. The silence of the government and regulators’ inertia has further deteriorated the situation.

The developed world has established highly regulated professionally strong systems of community pharmacies. Access to medicines is not open to patients and health consumers unlike in India. One has to use medicines under the guidance of healthcare professionals. The doctors diagnose and prescribe the medicine, the pharmacist checks the prescription for appropriateness of drug versus disease, doses, and duplication in prescription, and discusses with the patient to gather information about lifestyle issues affecting the health of the patient and prepare a customized care plan and explain to the patients about drugs he is going to use, side effects and possible adverse drug effects while using the medicine. In all, a community pharmacist provides service to the patients along with medicines. Here pharmacists are paid service fees either by the government or the insurance company because the government is obliged to provide patient safety and the insurance company saves money by keeping the subscriber's health.

To become a registered pharmacist in the developed country one has to complete Pharm D/B Pharm from an accredited college and should complete the requisite internship. After the internship one has to clear the licence public examination. The license is valid for one or two years. The number of licences depends on the requirement of pharmacists which is decided by the licensing authority. To renew a license, it is the responsibility of the pharmacist to qualify in licensing examination to continue as a registered pharmacist.

Strength
Indian pharmaceutical sector supplies over 50 percent of the global demand for various vaccines, 40 percent of the generic medicine for the US, and 25 percent of all medicines for the United Kingdom.

According to the Indian Economic Survey 2021, the domestic market is expected to grow 30 times in the next decade. India’s domestic pharmaceutical market stood at US$ 42 billion in 2021 and is likely to reach US$ 65 billion by 2024 and further will expand to reach US$ 120-130 billion by 2030. In terms of overall revenue, the Indian pharmaceutical market increased by 13.9 percent in January 2022. India is the largest producer of vaccines worldwide, accounting for ~60 percent of the total vaccines, as of 2021.

Regulations
There are two aspects in pharmacy, making quality medicines and establishing a system of quality use of medicine.

For making quality medicine, we have the Drugs and Cosmetic Act 1940 and Rules 1945, Indian Pharmacopoeia Commission, and several laws and regulations about the pharmaceutical industry. The strict practice of rules and regulations helped us to become global leaders in the pharmaceutical sector. The drug inspectors appointed by the State drugs control department ensure the sale and storage of medicines as per the Drugs and Cosmetic Act 1940 and inspect the premises of the retail pharmacy engaged in dispensing of medicines.

For the quality use of medicines, we have the Pharmacy Act, which gives provision for the establishment of the State Pharmacy Council, and the Pharmacy Council of India. Pharmacy Council is responsible for maintaining education standards for the registration of pharmacists and establishing professional practice by providing services to patients and health consumers by promoting pharmacy practice. Pharmacy Act of 1947 and various amendments like starting of the Pharm D program in 2008, Pharmacy Practice Regulations 2015, and the Pharmacy Practice B.S. program are revolutionary amendments.

Weakness
Although India has emerged as a global leader in manufacturing formulations, it has remained backward in the quality use of medicines. India is very much infamous for making product centric market rather than a patient-focused market. Medicine prices fluctuate from high to low. To control medicine prices, the government of India has made several efforts to establish the National Pharmaceutical Pricing Authority, and Jan Aushadhi Act, and several attempts to avert the excess profiteering by the industry. The nexus between the pharmaceutical industry, doctors, and retail pharmacies in exploiting patients and health consumers is an open secret in the country. The failure to implement the provisions of the existing laws is mainly the cause of the rampant irrational use of medicines in the country.

Opportunity
The major challenge in updating the quality use of medicine is to sensitize the public about self-medication and the importance of learning registered pharmacists in the use of prescription medicine. This module is a common module observed in regulated countries. Hence, it is very important to update the regulations in India. We have enacted Pharmacy Practice Regulations 2015, and Pharmacy Practice Regulations 2021 in our country.

The Pharmacy Council of India should take the leadership and begin the implementation  Pharmacy Act 1947,  and Pharmacy Practice Regulations 2015 immediately.  The Pharmacy Council of India should create a good business module so that pharmaceutical care is provided to all patients and health consumers who are using the medicine. The funding for Pharmacovigilance is entrusted to the industry by the PvPi program wherein they have made the manufacturer carry out and submit the Pharmacovigilance data. On similar grounds pharmacy practice services can be given to individual registered pharmacists by government or insurance companies. There is a need to supervise the use of medicines in the public. The Australian government announced 20 Australian dollars to a registered community pharmacist for providing pharmaceutical care to patients.

Threat
Pharmacist of Indian origin has become successful in providing pharmaceutical care all over the world. In India, there is no payment model for a registered pharmacist for providing pharmaceutical care to patients. Pharmacists are required to earn money by margin on sales of prescription medicine provided by the manufacturer. The margin on MRP is fixed by the marketing team. There are no guidelines or uniformity on the margin of sales to the registered pharmacist.   

In India, retail pharmacies in general encourage patients to buy more medicine as their income is linked to the volume of sales. Hence, instead of warning the patients about the irrational use of medicine, retail pharmacy encourages the patients and health consumers to buy more medicine, which is not seen in the developed world. The pharmacist abroad takes care of the patient so well that the public is proud of the pharmacist and takes pride in saying “My Pharmacist”.

The entry of online pharmacies by corporate challenging the retail pharmacy in India by garbing the business by luring patients and health consumers by providing 30-40 percent discounts. As it is a blatant crime against the law of the land and illegal practice. It is wrong because it contravenes the Drugs and Cosmetics Act 1940, and Pharmacy Act 1947, which mandates supervision by registered pharmacists which is not practiced in online pharmacies.

The registered pharmacist and business owners who are managing the retail dispensing pharmacy in India. They do not have any motivation or capability of providing any pharmaceutical care to the patients. There is together resistance and opposition which may hinder the implementation of Pharmacy Practice Regulations. At the same instance ignoring the implementation of the Act is going to hamper patient safety.

Pharmacy Practice Regulations 2015 (PPR 2015)
The Pharmacy Practice Regulations 2015 was enacted under Pharmacy Act 1947, and the Pharmacy Council of India was to implement the Act throughout India. The Act talks about the roles and responsibilities of Registered pharmacists (RPh) in patient safety. It defines pharmacy practice as the interpretation, evaluation, and implementation of prescriptions written by registered medical practitioners (RMP), further, it empowers the Registered Pharmacist to actively participate in drug-device selection and drug administration along with doctors and nurses. The registered pharmacist is supposed to do drug regimen reviews and carry out drug-related social pharmacy research.

The PPR 2015 recognizes pharmacy as a profession and mandates every new Registered Pharmacist to sign a declaration on the code of ethics at the time of registration. The code of ethics emphasizes every newly registered pharmacist to motivate and uphold professional responsibility and commitment to adhere to values and ethical behavior. Further,  it allows the Registered Pharmacist to charge the patients and health consumers a service fee. Pharmacy Practice Regulations 2015 mandates to display of the name of the owner of the pharmacy, and registered pharmacist names along with the registration certificates, and licenses in a prominent place in the pharmacy.
 
Pharmacy Practice Regulations 2015 that a registered pharmacist is obliged to provide professional services as per the provisions of Drugs and Cosmetics Rules 1945 and Schedule N of the Act. It says no other person other than Registered Pharmacist should engage in providing pharmaceutical care. On receiving a prescription Registered Pharmacist should check the following matters; correctness of dose, duplication of medicine in prescription, drug-drug interaction, drug-food interaction, incorrect drug dosage or duration of treatment, drug allergies, and drug abuse and misuse.

In case a registered pharmacist is found to do unethical practices, the Pharmacy Practice Regulations 2015 prescribes punishment and cancellation of the registered pharmacist’s license.

Conclusion
Every therapeutic agent/drug is a technical product that needs thorough knowledge while using them. Although doctors write prescriptions, the Registered Pharmacist should interact with the patient and with his professional knowledge and skills will be able to optimize the prescription so that the patient gets more benefits and avoids or minimizes the risk involved while undergoing a treatment. The introduction of Pharm D, Pharm D (PB), and BS in Pharmacy Practice by the Pharmacy Council of India is an attempt to update pharmacy practice. The new syllabus of the Diploma in Pharmacy emphasizes on social pharmacy and pharmacy practice.

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