Reinstating its commitment to ensure high quality healthcare services to patients across the spectrum, the central government has set apart Rs.5000 crore for the All India Institute of Medical Sciences (AIIMS). Apart from that, the government also announced its decision to set up four new AIIMS in Andra Pradesh, West Bengal, Maharashtra and Uttar Pradesh.
From the allotted funds Rs.900 crore will be dedicated for each AIIMS to be functional at the earliest. The government also informed that the six new AIIMS like institutions situated in Bhopal, Patna, Jodhpur, Rishikesh, Raipur and Bhubaneswar have already started its functions and that in the future they plan to add one AIIMS like institution in each of the states.
While delivering his maiden budget, finance minister Arun Jaitley announced that they will provide free drug and diagnostic services to needy patients along with establishing 12 new government medical colleges plus dental facilities across the country. To ensure availability of high quality drugs to the patients the Center will be providing funds to set up new drugs and food testing labs across the country apart from supporting with funds to modernise and technically upgrade the 31 existing labs. The Centre for the first time has decided to set up 15 new rural healthcare regional centers to address the lacunae in addressing the healthcare needs of the patients in the far-flung region of the country.
With a view to inspire and encourage new entrepreneurs to take up good projects, the government has set up a committee for MSME and has allocated Rs.10,000 crore for the same. Further the FM promised to set up three dedicated biotechnology parks in Pune, Kolkatta and Mohali through the public private partnership (PPP) route and stressed that there needs to be more PPP with private and foreign institutes to encourage biotechnology in the country.
In a first of its kind initiative, the Central Drugs Standard Control Organisation (CDSCO) will be investing Rs.50 crore under the 12th five year plan, for setting up a unique training academy in Hyderabad. The Government has already sanctioned the funds for the same and once completed, the academy will be an ideal training ground for not only the newly recruited officials from the drug regulatory body but also for all the existing employees as well.
Under the sanctioned proposal, the CDSCO will be building a state of the art academy in Hyderabad considering that it is one of the major pharma hub of the country, with many pharmaceutical companies in and around the area. Moreover, it is also strategic located close to other major pharma manufacturing states like Maharashtra and Gujarat
A highly placed source from the CDSCO’s office further informed that the training programme will be mandatory with all the members compulsorily undergoing the training programeme in three phases. The first will be the induction phase where new entrants will be given a detailed training on their function etc as per international standards. The second phase will include basic training for all the officials to keep them updated on the changing trends and the third one will consist of advanced training programme which will be on a re-current basis for the all the drug officials to under go.
According to the source, lack of trained manpower had always been a bone of contention affecting the reputation of the Indian drug regulatory body, which had almost always led to question the quality of services rendered by them. Thus, this move is aimed at improving the standard of services so that they can be at par with their international counterparts.
“Establishing such an academy will help in addressing the lacunae in system which had prevented the Indian regulatory officials from being at the top. One of the biggest thrust behind this move is to strengthen the regulatory system by training the officials as per the latest developments across the globe. This they aim to do by training new recruits and by providing refreshers course to the existing employees to update them on the frequently changing regulatory requirements. This will not only improve the standard of services, by keeping the officials abreast and prepared for meeting all the challenges thrown to them due to the frequently changing market dynamics,” informed the source.
The Maharashtra Food and Drug Administration (FDA)’s online WHO GMP certificate generation system, introduced by the FDA around two years ago, has now been upgraded through a robust IT backed system to such a level that the FDA is now able to provide the WHO GMP certificate to the exporters in 10 days.
Besides creating an electronic storage of data for easy retrieval at any time, the new online system developed by the FDA ensures avoiding duplication or counterfeiting of the certificates by assigning a software generated unique authorisation code to each certificate. Among the other unique attributes of the system, the SMS delivery system keeps the manufacturers updated when they are offline and authentication of the certificates can be verified by the authorities very easily.
The new system will go a long way in boosting the exports from the state as this new system will help manufacturing units to get WHO GMP certification for exports in 10 days time as compared to three months in the past.
The manual process was time consuming and entailed scrutiny of the application at three levels by the concerned authorities which once approved was sent by post as a Compliance Letter. This system was followed from 2000 to August 14, 2012.
Earlier, joint commissioner (HQ) was designated for signing the various certificates issued under the WHO GMP certificates. Manufacturers from across the state had to come to Mumbai to apply for the certificates and had to submit a sizeable amount of data in the form of papers. The application thus received was cumbersome as it was first received by the drug inspectors at WHO-GMP section and then by the assistant commissioner, WHO- GMP section followed by the final signatures on the certificates by the joint commissioner (HQ).
There are 1703 manufacturing units in the state out of which 247 units are WHO GMP certified. Exports of medicines worth Rs.15,500 crore have been accounted from Maharashtra in the year 2013-14. There are 883 allopathic units, 452 ayurvedic units, 31 homoeopathic units and 337 cosmetic product units across the state.
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.
While Maharashtra Food and Drug Administration (FDA) efforts to implement uniform and good prescription practices by launching a model prescription format is on since February, a new revised model prescription format is currently being drafted by Medical Council of India (MCI) in consultation with Maharashtra Medical Council (MMC), State Pharmacy Council and FDA.
Scheduled to be out in coming two weeks time, the revised model prescription format would be an answer to the practical difficulties faced by physicians in implementing FDA’s model prescription format like writing the names of the medicines in Capital Letters, patient’s address, specifying doctor’s qualification and registration number in addition to giving generic drug names.
MCI will hold a meeting of all the stakeholders comprising of state council presidents and MMC on May 4, 2014 in Delhi to contemplate on issues faced by physicians in implementing FDA’s model prescription format which was issued on February 28, 2014 by the hands of Chief Minister to discourage irrational use of drugs and combat multi-drug resistance.
According to Dr Kishor Taori, president, MMC,”We will be consulting Maharashtra FDA based on the recommendations of the meeting with the stakeholders to come out with a new model prescription format within 15 days. Maharashtra FDA has done an excellent job in coming out with the format as it will stall quackery but it needs to be made simpler and physician friendly.”
As per the contentious FDA format, it is statutory requirement to mention name of the prescriber on cash or credit memo of the drugs under Rule 65(3) and authenticate prescription. Therefore, the prescription shall bear doctor’s full name as mentioned in her or his registration certificate. To know competency and genuineness of prescriber, the prescription shall bear doctor’s primary qualification such as MBBS or BAMS followed by subsequent qualifications. Prescription shall bear the registration number of doctor’s registration with their respective council. The registration number should be prefixed with letters indicating the council in which doctor has registered her or his name.
“MMC plans to have simpler and more practical prescription format in the near future. It is tough for doctors who have to write prescriptions every five minutes to follow the FDA model,” an MMC official said.
The FDA format also states that it is statutory requirement to mention the address of the prescriber on the cash or credit memo of the drugs under Rule 65 (3) and the patient and pharmacist should know where the prescriber is practicing and, therefore, prescription shall bear complete address of clinic or hospital where the prescriber is practicing. The prescription shall have telephone number and e-mail address of prescriber.
As per the Rule 65 (10) prescription shall be dated and prescription shall specify the name and address of the person for whose treatment it is given or name and address of the owner of the animal if the drug is meant for veterinary use.
The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulation, 2002 under Indian Medical Council Act 1956 under Code of Medical Ethics at 1.5 prescribes as “Every physician should as far as possible prescribe drugs with Generic names and he or she shall ensure that there is a rational prescription and rational use of drugs”. Therefore, prescription shall bear the name of medicine as Generic name. The name of medicine should be in Capital letters in legible manner. If the prescriber is not sure about generic name he shall add following instructions on the prescription above her or his signature. “Or any other cheaper generic medicine as per choice of patient.”
Prescription shall invariably bear strength of the medicine. Eg. paracetamol tablets 500 mg., amoxycillin capsules 250 mg and shall also bear a proper dosage form of medicine prescribed. eg. tablets, capsules, syrups, creams etc.