The All India Organization of Chemists and Druggists (AIOCD) and its state affiliate units will soon approach the union health ministry to demand deferment of the implementation of Schedule H1 as it is being misused by quacks in remote parts of the country as there are drawbacks and ambiguities in the Schedule in its present form.
A letter to this effect has already been sent to the Members of Parliament (MPs) recently. According to the trade body, Schedule H1 in its current form is draconian and amounts to a non-bailable offence if not complied with.
Most of the chemists across the country have not been able to follow the newly amended Schedule H1 which has come into effect in the country from March 1, 2014 due to lack of awareness, cumbersome record keeping, lenient regulatory enforcement and the cost to set up a robust electronic system.
Offenders for non-compliance of Schedule H1 may face penalty ranging from FIRs and cancellation of licenses based on the merit of the case. The central government in September 2013 had amended the Drugs and Cosmetics (D&C) Rules to insert Schedule H1 to curb the indiscriminate use of antibiotics and some other vital drugs, by placing 46 antibiotics under this special category.
AIOCD claims to represent over 7 lakh chemists from across the country. The trade body also reasons out that most of the states except Maharashtra have not been able to implement it as it has taken almost three months for the state drug controllers to sensitise the chemists towards its implementation since it was introduced on March 1, 2014. Moreover, physicians from other systems of medicine have been practicing it in most of the states despite their ineligibility which is detrimental to patient safety.
Only a registered medical practitioner from allopathy is eligible to prescribe Schedule H1 drugs. Among other issues, it has also been argued by AIOCD that implementation of Schedule H1 has become a very expensive proposition for the patient in emergency situations when the pharmacist denies Schedule H1 drug to the patient and asks for a fresh prescription from a physician. The patient has to go the extra mile to get the drug prescribed again at a hefty consultancy fees from the physician ranging from Rs.200 to Rs.1000.
Clarity has also been sought on whether computerised bill is an authorised version or the chemist has to adhere to the manual billing system for compliance to Schedule H1. “The purpose of Schedule H1 has not been understood by the public and that only pharmacists have the onus of maintaining the register is ironical. Besides this, due to the shortage of MBBS doctors in many parts of the country, medical store owners will have the leniency to produce fake bills by putting names of doctors on the bill and rake in profits at the cost of patient safety,” said a pharmacist.
Committed to helping the pharmacist community to curtail their escalating healthcare costs, the Kerala state pharmacy council has started a scheme of health insurance cover for its registered pharmacists. The plan will benefit the family members of the pharmacists as well.
‘Apart from the pharmacists, the plan would also benefit the members of pharmacy council forums and non-pharmacist proprietors and owners of pharmacies on account of their long experience and association with pharmacy profession”; said B Rajan, president of KSPC.
According to him, this is the first health insurance scheme for registered pharmacists introduced by a state pharmacy council. The scheme has come into effect on April 1 this year and it is implemented through United India Insurance Company which signed an MoU with the pharmacy council in this regard.
While briefing Pharmabiz, Rajan said the premium starts with Rs 2300 for an insured amount of Rs.1 lakh, Rs.2875 for two lakh, Rs.3450 for three lakh, Rs.4025 for four lakh and Rs.4425 for five lakh. The policy has to be renewed every year. The medical stores and the wholesale premises can also be brought under the coverage.
“The enrollment of pharmacists to the scheme had commenced in September last year and we hope that about 50,000 registered pharmacists in the state can avail of the benefit. Within one month’s time, 1500 registered pharmacists have been enrolled into the scheme. Though there are 50,000 pharmacists registered with the Council so far, those renew their registration every year and practice the profession is only 25000. The pharmacists and their family members will come under the scheme”, he said.
He further said the premium for the scheme is very low compared to other health insurance plans available at present. In the scheme, all the diseases including chronic illness will be covered. Maximum age limit for taking policy is 70 years and it is a lifelong scheme. The council proposes to bring all the registered pharmacists under the insurance scheme shortly.
Apart from the insured amount, the benefits include ambulance charge of Rs.2000 in case of emergency and free accessibility of IP rooms, ICU and reimbursement of claims for treatment in non-net work hospitals. Maternity benefit is covered upto Rs.15000 for normal delivery and Rs.25000 for caesarian. Expenses incurred for 30 days before hospitalisation and for 60 days after it are also eligible to be availed through the scheme, said the Council president.
The Bangalore District Chemists & Druggists Association (BDC&DA) has urged the union health ministry to omit Clause (G) in the Drugs & Cosmetics Act (D&C Act) which deals with supply of drugs specified under Schedule H1. The clause insists that all pharmacy outlets would need to maintain a separate register recording the details about the quantity of drugs sold and patient name for a period of three years.
According to the Association, the government should omit Clause (G) because pharmacists are hauled up by the state drug inspectors for not providing the details in a legible way.
“The drugs control departments are independent entities under the respective state governments which enforce the D&C Act & Rules and Drugs Price Control Order 2013, which are central government Rules. Therefore Clause G could be deleted as it is a common problem encountered by all chemists & druggists”, BDC&DA president V Hari Krishnan told Pharmabiz.
Further, the Association has also highlighted that the key cause of non compliance of Clause (G) is the mushrooming of pharmacy outlets in an unorganised manner. Here the Rule 64 (2) of the D&C Act is not adhered. The state drugs control departments should only grant trade licenses to outlets with a minimum area 10 sq. metres, having a registered pharmacist, along with a refrigerator in working condition and racks for storage of medicines. But BDC&DA has seen that the non-adherence to the Rule 64 (2) of the D&C Act has led to a haphazard growth of pharmacy outlets, thus causing difficulties to comply with Clause G, he added.
Although Schedule H1 permits sale on minimum unit packs, the public needs to be made aware on the issue. It is also important that medical practitioners should look to prescribe generics and not brand names. The latter is more affordable for patients who should be made aware about this. Patients should purchase the same on valid prescription to prevent chemists being harassed. Moreover, the doctors do not follow a prescription code as medicines advisories are communicated on any strip of paper with no indication of the doctor’s name or registration details, said Krishnan.
The BDC&DA president stated that the pharmacy retailers and wholesalers are rendering yeoman service enabling access to medicines across the country. But the pharmacists are being neglected by the government in terms of being burdened with regulations without taking into consideration the minimum business security for their livelihood. There are no adequate margins provided to the infrastructural costs in maintenance of pharmacy outlets.
In order to enhance earnings, the pharmacy outlets should be provided an additional percentage for maintenance of records as per the Drugs & Cosmetics, (Fourth Amendment) notification Rules 2013. Besides registered pharmacists need a fixed pay scale. In addition, there should be a minimum trade margin of 20 per cent to retailers on MRP and 10 per cent to wholesalers on price-to-retailer (PTR) on all formulations, stated Krishnan.
When the debate over whether medical professionals or highly qualified pharmacists (Pharm D graduates) should conduct the Pharmacovigilance Programme of India (PvPI) is still continuing among doctors and pharmacists, different views and opinions are coming out from both the professionals and academicians in the fields.
Dr P S Bhagavan, former deputy director of pharmacy in the ministry of health in Karnataka government has observed that PvPI should be headed by a pharmacist, preferably a clinical pharmacist with Pharm D qualification. He said pharmacovigilance is an activity under pharmacy practice and not under medical practice.
According to him, the term pharmacovigilance has come from the concept of ‘pharmacy-vigilance’ and not from an idea of pharmacologists doing vigilance work. “If it were to be ‘pharmacologists do vigilance’, then what they were doing all these years confining to lab experiments” he asked.
Pharmacovigilance is both a monitoring of adverse reaction as well as an audit programme. It is a program based on documentation, he commented. According to him, the doctors should shun their idea and mindset that pharmacists should work under their control. It is this irrational mindset that leads to non-medical and non-pharmacy administrators to head the drug logistic in the government sector.
Whereas, Dr Binay Kumar, assistant professor, department of forensic medicine and toxicology, All India Institute of Medical Sciences, Patna observed that the Indian Pharm D graduates were not capable of doing anything other than dispensing drugs prescribed by physicians.
“They are not even able to recognize signs and symptoms in patients. They should work under the supervision of physicians, pharmacologists etc. Many experienced MBBS doctors are very competent. So it is not correct that MBBS doctors should be debarred from prescribing new drugs as stated by Dr Atmaram Pawar”, he commented.
Dr M C Gupta, medical-lego consultant from New Delhi said ADR reporting is very important, but usually non-existent in Indian hospitals because of lack of knowledge, time and attitude on the part of doctors.
“When 150 PvPI centres are existing in India, they need to pool their data and views, and issue a consensus statement as to how ADR reporting should be strengthened and by whom. There is nothing basically wrong in Pharm D personnel helping in ADR”, Dr Gupta said.
Demanding that the retail pharmacy stores in the country should be allowed to run without full time presence of qualified pharmacists and urging the union government and the Pharmacy Council of India (PCI) to drop the move to amend the Pharmacy Act for making degree as the basic qualification for registration, the All India Chemists & Distributors Federation (AICDF) has decided to hold nationwide protest agitations from next month.
To kickstart the all India agitation, the Federation will stage a protest Dharna at Jantar Mantar in New Delhi on March 24, for which it has started gathering support from all the stakeholders of the pharma trade industry.
According to Joydeep Sarkar, general secretary of AICDF and the leader of the agitation movement, the Federation would prove its claims about the Act in the court. The Act should not be amended to make degree in pharmacy as the basic qualification to run a retail medical store.
“The intention behind the amendment plan of the PCI is to eradicate the present retail and wholesale traders from the market. If such a law is enacted, a graduate in pharmacy alone shall be eligible to run a retail pharmacy store. No provision of Pharmacy Act compulsorily demands that a qualified pharmacist should be present in a retail drug store always. We are going to prove it,” he told Pharmabiz.
AICDF, whose majority of members are dealing in wholesale drug trade, has also approached the biggest trade body, All India Organisation of Chemists & Druggists (AIOCD) to support and take part in the agitation. According to sources, more than five thousand drug traders, representing various organisations from across the country, will assemble at Jantar Mantar and join the dharna against the PCI’s plan to introduce a draconian law by way of amendment, said Joydeep Sarkar from Kolkata.
“The association will not stop the protest agitations until the government withdraws from its decision to effect a new Rule intentionally to expunge those proprietors who have been engaged in the drug business for decades. These traders were in the field even before the Pharmacy Act came into being. If the new Rule is introduced, they will be asked to vacate the stores on account of being non-pharmacy graduates. Though the traders are not qualified in pharmacy subject, they are all educated and well-trained in the pharmaceutical business which is one of the supporting pillars of healthcare system,” he added.
Pranab Kumar Chakraborthy, the general secretary of Pharmaceutical Traders Association of Bengal (PTAB), who takes a leading role in the state to mobilize the traders, said the retailers and wholesalers are dealing in the sale of packed medicines only and they are not compounding any medicines in their pharmacy like what was happening in olden days. The medicines are sent to the medical shops by the manufacturing companies which are inspected for all phases of manufacture by regulatory staffs. From the production to the delivery of the packed products, there is no role for the traders and everything is monitored in a phase-wise manner by scientists and qualified pharmacists. The traders have no role either in the production or packing of the products. They just sell the well-packed products on the prescription of qualified doctors. Hence, pharmacist’s service is not necessary for selling the packed medicines in a medical shop, he opined.
Chakraborthy further alleged that there might be conspiracy by big national and international players to expunge all the wholesalers and retailers from the huge pharma market of our country. He appealed to the government to withdraw from enacting such a law that would spoil the lives of lakhs of people in the country and allow the experienced traders to run the business and ensure smooth health delivery system.
To a question, Joydeep Sarkar said, in Kolkata, PTAB has started an Academy of Pharmacy Management & Guidance (APMG) to train the unqualified staffs working in the retail stores. He said all the states in India are facing serious shortages of qualified and registered pharmacists, so it is difficult to employ registered pharmacists in every shop for 24 hours business. Employing full time pharmacists in community pharmacies is like wasting precious and skilful national wealth and they could be utilized in the other areas of the health sector to serve the society in a better way, he added.