SWOT analysis of Pharmacy Practice Regulations 2015

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 in proper manner 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) pharmacist (from manufacturing to dispensing). India is called world pharmacy as they have emerged  as leaders in 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 are acceptable in rich and poor countries alike. The strict discipline is adopted while manufacturing formulations.

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

There seems to be no control over sale of medicine in the country, any body can walk into pharmacy and buy prescription medicine without a prescription. Especially antibiotics’ indiscriminate use has lead to the highly dangerous and multi drug resistant strains of bacteria. This style of selling of medicine has caused several  issues in the country. The drugs are sold like any consumer goods to the public, which is illegal and doing great harm to the health of public at large. The problem has lead to renting of certificate of registration which is mockery of Pharmacy Act 1947. It is very unfortunate that it has to lead to loss of the identity of pharmacist and pharmacy retail is controlled by private business owners family members rather than a registered pharmacist. There is no body to check the contents written in prescription and explain about drugs, dose storage as well usage of medicine dispensed in retail pharmacy. 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 in order to capture the market by luring with attractive trade discounts directly to the patients and health consumers. The silence of government and regulators’ inertia has further deteriorated the situation.

Developed world have established highly regulated professionally strong system of community pharmacy. 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, pharmacist to check the prescription for appropriateness of drug verses disease, doses, duplication in prescription and discuss with the patient to gather information about life style 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 government or insurance company because government is obliged to provide patient safety and insurance company saves money by keeping the subscribers health.

In order to become a registered pharmacist in 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. Licence is valid for one or two years. The number of licence depending on requirement of pharmacists which is decided by the licensing authority. In order to renew licence, it is the responsibility of pharmacist to qualify in licensing examination to continue as registered pharmacist.

Strength
Indian pharmaceutical sector supplies over 50 per cent of the global demand for various vaccines, 40 per cent of the generic medicine for US and 25 per cent of all medicines for 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 per cent in January 2022. India is the largest producer of vaccines worldwide, accounting for ~60 per cent 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 Drugs and Cosmetic Act 1940 and Rules 1945, Indian Pharmacopoeia Commission, and several laws and regulations pertaining to pharmaceutical industry. Strict practice of rules and regulations helped us to becoming global leaders in pharmaceutical sector. The drugs inspectors appointed by State drugs control department ensures sale and storage of medicines are as per Drugs and Cosmetic Act 1940, and inspecting the premises of retail pharmacy engaged in dispensing of medicines.

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

Weakness
Although India has emerged as global leader for manufacturing of formulations, it has remained backward as for quality use of medicines. The India is very much infamous for making product centric market rather than patient focused market. Medicine prices fluctuate from high to low. In order to control medicine prices, the government of India has made several efforts by establishing the National Pharmaceutical Pricing Authority, Jan Aushadhi Act, and several attempts to avert the excess profiteering by industry. The nexus between pharmaceutical industry, doctors and retail pharmacy in exploiting the 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 for rampant irrational use of medicines in the country.

Opportunity
The major challenge in updating quality use of medicine is to sensitize the public about self medication and importance of learned registered  pharmacist in use of prescription medicine. This module is 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,  Pharmacy Practice Regulations 2015 immediately.  The Pharmacy Council of India should create good business module so that pharmaceutical care is provided to all patients and health consumers who are using medicine. The funding for Pharmacovigilance is entrusted to the industry by PvPi programme where in they have made the manufacturer to carry out and submit the Pharmacovigilance data. On similar grounds pharmacy practice services can be given to individual registered pharmacist by government or insurance companies. There is a need to supervise the use of medicines in the public. Australian government announced 20 Australian dollars to a registered community pharmacist for providing pharmaceutical care to the patients.

Threat
The pharmacist of Indian origin have become successful in providing pharmaceutical care to all over the world. In India, there is no payment model to a registered pharmacist for providing pharmaceutical care to patients. Pharmacist are required 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 margin on sales to the registered pharmacist.   

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

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

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 all 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 hamper patient safety.

Pharmacy Practice Regulations 2015 (PPR 2015)
The Pharmacy Practice Regulations 2015 was enacted under Pharmacy Act 1947, and Pharmacy Council of India was to implement the Act through out India. The Act talks about the roles and responsibility of Registered Pharmacist (RPh) in patient safety. It defines pharmacy practice as interpretation, evaluation and implementation of prescriptions written by registered medical practitioner (RMP), further it empowers with the Registered Pharmacist to actively participate in drug device selection and drug administration along with doctors and nurses. The registered pharmacist is supposed do drug regimen review 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 code of ethics at the time of registration. The code of ethics emphasizes every newly registered pharmacist to motivate and uphold the professional responsibility and commitment to adhere to values and ethical behaviour. Further,  it allows the Registered Pharmacist to charge the patients and health consumers a fee for service. Pharmacy Practice Regulations 2015 mandates to display the name of  owner of pharmacy, registered pharmacist names along with the registration certificates, licenses in prominent place in the pharmacy.
 
Pharmacy Practice Regulations 2015 that 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 registered pharmacists’ license.

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