Indian Pharmaceutical Association (IPA) has strongly condemned the recent recommendations of the Standing Committee of the Union Ministry of Chemicals & Fertilizers to review the licensing conditions under the Drugs and Cosmetics Rules to facilitate the dispensation of essential drugs by non-pharmacists.
The committee, with MPs as its members, was formed to find ways to improve the availability of Essential Medicines (EDMs) to the general population. IPA alleged that the recommendation is against the present mandatory involvement of registered pharmacists in distribution and sale of drugs in India.
According to IPA, the solution suggested by the committee to improve the access of modern medicines is one of the most retrograde steps to be taken in the matter in recent times.
“The Committee's recommendations to impart short training to educated persons other than pharmacists to make essential drugs available to general public defies logic”, Prafull D. Sheth, President, IPA said.
However, IPA welcomed the plans of the government for the creation of Standard Treatment Guidelines (STGs) as a ready reference for the physicians to promote the EDMs and rational use of drugs. Claiming it as “a step in the right direction”, they pointed out that the Jaipur Declaration of IPA goes a step further and recommends that qualified pharmacist be trained in STGs so that, in rural areas where doctors are not available, they can promote EDMs and RUDs.”
The Jaipur declaration for essential medicines was jointly made by IPA, the Delhi Society for Promotion of Rational Use of Drugs (DSPRUD), the Rajasthan Society for Promotion of Rational Use of Drugs (RSPRUD), the WHO-India Essential Drugs Programme, the Delhi Pharmaceutical Trust (DPT), SEARPharm Forum and the All India Organization of Chemists and Druggists (AIOCD) last year.
EDMs have profound impact on health – Effective drug treatment now exists for most leading infectious diseases, including acute respiratory infections, HIV/AIDS, Malaria, TB and diarrhoeal diseases, as well as leading non-communicable diseases such as ischaemic heart diseases, diabetes and cancer. Prescribing and dispensing by persons who are not qualified will lead to rampant self-medication with disastrous outcomes for the health professionals and regulators. The relevant knowledge is not available with a non-pharmacy person with short training involved in sale and distribution of items handled by the Public Distribution System (PDS) or 'Sarvapriya Scheme' shops, he said.
“The pleas of shortage of medicines particularly in rural and remote areas are being raised by ill-advised vested interests. The ground reality is that majority of Indian population is deprived of even essential medicines for a variety of reasons including poverty, illiteracy, unaffordability and non-availability of qualified doctors in rural and difficult areas. But regardless of a doctor in an area, a medicine shop is bound to be there and the pharmacist services are available in a rural area, which is commendable. There is already a provision in the Drugs and Cosmetics Rules (Schedule K), which exempts several household remedies if they are sold in a village having a population of not more than 1,000 persons and where there is no licensed dealer “ he pointed out.
Interestingly, International professional bodies such as the WHO and FIP have come out with Good Pharmacy Practice (GPP), Good Storage Practice (GSP) Guidelines. These guidelines recommend that national standards should be set for improving prescribing and dispensing of medicines by pharmacist's activities. The WHO has specially emphasised on the pharmacist's specific responsibility for assuring the quality of pharmaceutical products throughout the distribution.
Sheth feared that amending the law and removing the interface of pharmacists would turn most of the registered pharmacists redundant and jobless.
He said that any amendments in the Act should be thought of only after due consultation with the persons who are to be directly affected by the amendments. The country has to recognize pharmacists as the human resources for health (HRH). Unless it is done, the profession would face crises, which if not resolved in a short term, will result eventually in the complete breakdown of pharmaceutical services, he warned.
Sheth wanted a political agenda for development of health to be evolved in the country. “What required is advocacy to emphasize that pharmacists are among HRH and not to see them as the main hurdle in the way of enhancing the access of medicines particularly in the rural areas”, he said.
Professional organizations like Indian Pharma Graduates Association (IPGA) and Indian Hospital Pharmacists Association (IHPA) have also decided to protest against the recommendations of the committee.