The Food and Drug Administration (FDA) of Maharashtra has found four drums of Aurobindo Pharma’s antibiotic “Cefixime IP Compacted”, an Active Pharmaceutical Ingredient (API), to be substandard on December 21, 2017.
The APIs are used as raw material ingredients to prepare finished medicines. In response to the queries of The Indian Express, Aurobindo Pharma stated: “We found that there was a pilferage / theft / damage of subject material of your query during its transit/storage and on identification of such act, consignee has filed a police complaint which is currently under investigation.”
The Maharashtra FDA took “composite sample of API” from drum number 5, 7, 8 and 14 – which were manufactured by Aurobindo Pharma Ltd — having name “Cefixime IP Compacted” as label on each of them. These four drums belonged to the batch number 1711604662, according to Maharashtra FDA.
The composite sample was put under different tests by DP Awashank, Analyst, Maharashtra FDA. In his report dated December 21, 2017, Awashank concluded: “The sample, Cefixime does not comply with IP (Indian Pharmacopoeia) requirements for the tests, description, identification, PH, water and Sulphated Ash.” Therefore, he deemed the sample “not of standard quality”.
Form 18, which is a memorandum to government analyst from the drug inspector who picked up the sample, was also quoted in the December 21 report. The Form 18 stated: “Firm received 16 drums of this consignment in which API powder in these four drums is different in appearance than specification (monograph), Primafacie powder in these four drums is spurious. So, stock of these four drums prohibited. So, please test sample accordingly on top priority and also test for another ingredients if possible.”
The composite sample did not give any IP identification “for the presence of Cefixime Trihydrate”. According to the analyst report, “the sample also did not give any identification test for the presence of Ofloxacin, Ornidazole, Amoxycillin Trihydrate, Pottasium Clavulanate, Paracetamol, Phenylephrine HCL, Chlorpheniramine Maleate, Mefenamic Acid, Diclofenac Sodium and Bromhexine HCL”.
According to Drugs and Cosmetics, 1940, as well as Drugs and Cosmetics Rules, 1945, the PH value of the aforementioned API should be in between 2.6 and 4.1. However, the tests conducted by the Maharashtra FDA analyst found the PH value to be 10.02. The 1940 Act as well as 1945 Rules also state that the amount of Sulphated Ash should not be more than 0.2 per cent. The Maharashtra FDA analyst found that “Cefixime IP Compacted” contains 99.11 per cent Sulphated Ash content.
During 2016-17, the company earned Rs 3, 042 crore revenue from API sale, which was 20 per cent share of its total revenue. The 2016-17 annual report of Aurobindo Pharma stated: “This growth in revenue of high value APIs has been achieved after meeting the very large in-house demand for manufacture of formulations. In line with anticipated further increase in formulations business, the in-house capacity for API has been further raised, even as your Company has contracted additional, newer, alternate sources for APIs.” The remaining 80 per cent revenue — Rs 12, 045 crore — came from the sale of finished formulations.
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