Mumbai: The medical fraternity has raised questions about accountability for poor quality of drugs originating from substandard manufacturing facilities and emphasised the necessity of clear enforcement of quality care and safety of patients.
This backlash occurs in the wake of the National Medical Commission’s regulations, which advise doctors to exclusively prescribe generic medicines to avoid potential repercussions.
Quality and Safety assessments carried out at several stages
An official from a pharmaceutical company revealed that quality and safety assessments are carried out in several stages during the invention of medicines before they are approved, and often secure patents for the same. According to the United States Food and Drug Administration (USFDA), a generic drug or generic medicine is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.
The Secretary of the Maharashtra State Chemists and Druggists Association, Anil Navandar, suggested that considering India’s role of globally exporting 13-14% of medicines, the government should have weighed the implications of such rules and the impact it will make in the pharma industry. Additionally, this would give licence to certain pharma companies to manufacture substandard medicines without any quality check and control.
He further asserted that the prescription of generic drugs poses practical challenges, since several factors are involved in doctor’s evaluation depending on the disease. He said, “Moreover, if the government really wants to bring transparency then they should have equal pricing for all medicines so that all categories of patients can afford them. Secondly, this will create a misuse of antibiotics and it is cheap publicity by the government.”
Meeting with all chemist associations
A meeting with the attendance of all chemist associations’ is being held on August 19 to discuss the implications of the new NMC regulations.
Meanwhile, senior officials note that medical stores often refrain from stocking generics due to slim profit margins. Moreover, if generic options aren’t available, pharmacists may resort to substituting them with brands having a higher profit-margin, regardless of the quality being good or bad. Lastly, they note that the quality of all generic medicines is not the same.
“The guidelines should clarify whether this point in the guidelines is a must or suggested. Rather than urging doctors to prescribe generics, the government should promote the manufacturing of generics alone,” said senior official from the chemist associations.
OFFICIALS’ CLAIMS
Medical stores often refrain from stocking generics due to slim profit margins
If generic options aren’t available, pharmacists may resort to substituting them with brands having a higher profit-margin, regardless of the quality.
Quality of all generic medicines is not the same.
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