Last Updated on December 30, 2023 by The Health Master
The Karnataka State Registered Pharmacists Association (KSRPA) has now indicated to the government that it is time for not only reframing the Drugs, Cosmetics and Medical Devices Act but the Drug Price Control Order (DPCO) also. This is even as the government constituted a committee to frame a new law for drugs, cosmetics and medical devices.
Storage of drugs: The Association in its communication has submitted 25 points to the government which include mandatory air conditioning of all medical stores to ensure that the medicines are stocked in a controlled, cool and dry condition. This is because going by the temperature variations across the country, it could mar the potency of the medicines which are lifesaving.
Rule 64(1): In order to protect the future of the registered pharmacists, KSRPA has also called to amend Rule 64(1) so as to grant a sales license only to qualified registered pharmacists. It also called for stringent action against those outlets which did not have a presence of the registered pharmacist.
Schedule K: There is also a need for inclusion of certain drugs in Schedule K, set up a separate cell to monitor the sale of veterinary drugs, amend Rule 65 (11-A) to permit substitution of Schedule H, H1 and X drugs. The Janaushadhi stores need to be issued licenses only to the registered pharmacists.
Ashokswamy Heroor, president, KSRPA indicated to the government that amendments need to be made in the new law for drugs, cosmetics and medical devices to make it relevant to the current times and hence the effort to spell out the lacunae of the existing regulations.
State FDAs and CDSCO under one banner: We are also of the view that the state and central drugs control operations need to come under a single banner or if this cannot happen, then steps need to be taken to improve the efficiency of the drugs control departments across the state, said Heroor.
DPCO: Noting that while the DPCO has effectively controlled the soaring prices of the essential drugs, Heroor said it has not contained the costing of the non-scheduled generic formulations. Para 9 of the DPCO controls the MRP of scheduled generics drugs by way of ceiling price, but excludes the non-scheduled ones.
MBBS and B.Pharm course: Heroor also said that going by the review of the course curriculum of MBBS and B Pharm, it was amply clear that pharmacy graduates are more strong in areas like drug chemistry, pharmacokinetics and bioavailability.
Dispensing of drugs by Registered Pharmacist: Hence the suggestion is to permit qualified and registered pharmacists to prescribe drugs for common health problems and also during emergencies to administer the first line of therapy at the rural areas where access to MBBS doctors are difficult. Till a patient is rushed to a district hospital pharmacist could administer the drug as a pharmacist was far more reliable than a quack to fill this vacuum.
Training o adverse drug reaction: In order to further strengthen the public healthcare system, qualified and registered pharmacists can conduct training on adverse drug reaction and appropriate use of antibiotics to hospital staff.
Pharmacist at State and Centre healthcare: KSRPA has also called for government to appoint pharmacists as supervisors across Central and state healthcare institutions to bolster medical care access to patients.
Role of Pharmacist: Heroor said that the new rules are much desired to make the guidance for drugs, cosmetics and medical devices contemporary to the present day demand of proper handing, storage, preservation and quality assurance where pharmacists will play a prime role in the new drug regulatory landscape.
How to obtain retail drug license, click here
How to obtain Jan Aushadhi License, click here
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Self inspection of Medical Store :105 points, click here
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