IPA opposed amendment in Schedule K of D&C Rules by health ministry
Indian Pharmaceutical Association (IPA) strongly opposed the proposed amendment in Schedule K of Drugs & Cosmetics (D&C) Rules by health ministry. IPA is the largest association of Pharmacists in India & working not only for uplifting the pharmacy profession but also to ascertain that patients receives quality pharmaceutical care.
Recently Health Ministry had made amedment in Schedule K of D&C rules 1945 in which drugs can be supplied by Health Functionaries including Community Health Officers, Nurses, Auxiliary Nurse Midwives and Lady Health Visitors attached to Primary Health Centres/ Sub-Centres/ Health & Wellness Centres in rural and urban areas, Community Health Volunteers such as Accredited Social Health Activists (ASHAs) under the National Health Mission, and Anganwadi Workers.
Mr. Bhupendra Kumar Secretary General, IPA said in a notification, "According to Section 42 of Pharmacy Act, 1948, “No person other than a registered pharmacist shall compound, prepare, mix or dispense any medicine on the prescription of a medical practitioner. Whoever contravenes the provisions shall be punishable with imprisonment for a term which may extend to six month or with fine or with both.
Rule 123 of Drugs and Cosmetic Act exempt ONLY DRUGS SPECIFIED IN SCHEDULE K from the provisions of Chapter IV of the Act and the Rules made thereunder. NO EXEMPTION given to any person other than a Registered Pharmacist. Therefore, serial number 23 under the column “Class of Drugs” under the Drugs and Cosmetic Rules, 1945 is ILLEGAL and UNETHICAL and need to be deleted completely."
As per IPA, Schedule K exempt only the provisions of Chapter IV of the Act and Rules thereunder, which required them to be covered by a sale licence. It means only requirement of obtaining a sale licence is exempted and requirement of a Registered Pharmacist is nowhere exempted. These amendments will not only violate Drugs and Cosmetic Act, Pharmacy Act but also Article 16, Article 21 and Article 47 of Indian Constitution.
National Health Policy 2017 suggested for including pharmacists also for developing mid-level practitioners for rural areas i.e. Community Health Officer. But sadly, Health Ministry issued necessary orders for Nurses and Ayush doctors only, despite the fact that Pharmacists are more competent than other categories as mentioned in National Health Policy, 2017. And once again Govt. is trying to deprive them with their fundamental right to practice their profession for earning their livelihood.
Mr. Jasbir Mann and Mr. Vikas tushir, Gen. Sect. and president Akhil Bharatiya Pharmacop Association respectively said to PharmaTutor that, "It is sad to know the proposal put up by the Min. of health, Govt. of India to amend the schedule "K" of drug and cosmetic act . This is not just about amendment of a section it is about playing with the life of Citizen of India. Getting medicine distributed by un qualified person is like playing with the fire, govt should realise that it can bear a very serious consequences. Govt. Should realize that the medicine regulation is such an important aspect that the pharmacy act was formed just immediately after the freedom in 1948. Moreover this amendment is in contradiction of the section 42 of pharmacy act 1948, Which says that any medicine distributed without a registered pharmacist is punishable offence. Govt must understand that both things cannot go hand in hand."
"Most of the medicines are chemical entity and may toxic in higher proportion and this will promote miss use of medicines due to handle by unqualified people. Even small trainings are not sufficient for such people to understand medicines which we pharmacists learn in degree or diploma of pharmacy.", said Mr. BK Barman General sec, NPCC, Guwahati to PharmaTutor on telephone.
Various Pharmaceutical associations and pharmacists opposed this decision because it will not only supersede the qualification by unqualified but at the same time will make lakhs of Qualified Registered Pharmacists jobless and homeless in our own country.