The recommendation came during the 70th meeting of the Multidisciplinary Committee of Experts held on 05.08.2025, where the committee noted that Abbott Healthcare admitted to a typographical error in its original application filed on the Integrated Pharmaceutical Database Management System (IPDMS).
The Committee recalled that the retail price for the applied formulation was recommended in the 69th meeting of MDC held on 03.07.2025 at Rs.13 per tablet, being the lower of the claimed (13.00) and worked out price (Rs.71.71). The price was worked out by applying the Pronob Sen formula on the ceiling price of a Clarithromycin 500 mg tablet (Rs. 39.84 per tablet) applicable to the 6 months prior to the date of application, i.e., November 2024, as below:
Derived retail price as per recommendation of Pronab Sen committee: P(s) = P*[1+a.{(s-s*)/s*}]
Where: P(s) = price ceiling of the strengths
P* = price ceiling for reference strength s* s = strength in terms of API content
s* = reference strength
a = 0.8 for tablets/capsules and 0.7 for injectables.
= 39.84[1+0.80{(1000-500)/500}] = Rs. 71.71 (excluding GST) per tablet
However, following the above, Abbott Healthcare submitted a representation on 16.07.2025, stating that there was a typographical error in their Form I submission on IPDMS and claimed the price was incorrectly stated as Rs. 13 per tablet (Rs. 91 per strip of 7 tablets) instead of the correct Rs. 91 per tablet.
Regarding the above, the Committee deliberated upon the matter and noted that the ceiling price for Clarithromycin Tablet 250 mg and 500 mg applicable to 6 months prior to the date of application, i.e., November 2024, was Rs. 23.89 and 39.84 per tablet, respectively.
Furthermore, the committee noted that there is no other company marketing the applied formulation.
In view of the above, the committee observed that Abbott Healthcare, in its representation on page 1, last paragraph, mentioned, "On analysis, it is observed that there has been a typographical error on our side while filing the form I in IPDMS."
Finally, the committee noted the serious error committed by the applicant and recommended,
"The retail price for each extended-release film-coated tablet contains Clarithromycin IP 1000 mg at Rs.71.71 per tablet, as worked out by applying the Pronab Sen formula as detailed at para 1 above. The committee also directed the applicant to ensure avoiding such negligence, which could affect the committee deliberations and unnecessarily delay the disposal of Form I applications"
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.