Maharashtra Food and Drug Administration (FDA), during its routine inspection in the month of May, has held 15 sets of scalp vein not complying to the specified standards of quality. A total 32 not-of-standard-quality drugs were found in the month of May.
According to the latest data released by the Maharashtra FDA, one substandard drug sample was from manufacturer in Chandigarh, 14 in Gujarat, five from Himachal Pradesh, nine from Maharashtra and four from Uttaranchal.
The highlight of the list is that 15 sets of scalp vein were listed of non-compliance. Out of these, five samples were from Alpha Medicare & Devices; four samples from Bharatiya Surgicals; one each from Hutch Surgicals, K N Surgicals and Royal Surgicals of Gujarat. Three such samples were found from MRK Healthcare of Maharashtra. The sample from Royal Surgicals was listed for not complying with specification for scalp vein set with respect to test for tube length and test for sterility as given in the protocol. Not-of-standard quality scalp vein set samples from Alpha Medicare & Devices, Bharatiya Surgicals, K N Surgicals and MRK Healthcare were listed for not complying with IP requirements for sterility as given in the protocol.
Others manufactures among the list of not-of-standard-quality drugs were Kanak Pharma from Chandigarh; Link Surgicals and Micron Pharma from Gujarat; Arion Healthcare, Kanha Biogenetic, Quixotic Healthcare, Saibliss Drugs & Pharma and Spanker Biotech of Himachal Pradesh; Ashapura Distributors & Suppliers, Modern Sales Corporation, Naxper Pharma and Bassica Pharma of Maharashtra; and Auroville Labs, Pro Labs, Qualis Pharma and Zorex Remedies of Uttaranchal.
The state FDA routinely picks up random samples of drugs from chemists and druggists and send for testing. The department will soon issue show cause notices to the companies.