Against the backdrop of cases of non-compliance to good manufacturing practices (GMP), Maharashtra Food and Drug Administration (FDA) has canceled WHO GMP Certificate of two Maharashtra based WHO-GMP units -  BDH Industries Limited, Mumbai and Sydler Remedies Pvt Limited, Pune.  

The state regulator took action on the basis of Technical Report Series (TRS) issued by World Health Organisation (WHO) as a part of its guidelines on auditing and verifying of compliance of WHO- GMP units.

GMPs is based on a criteria involving factors such as sanitation and hygiene, qualification and validation, self-inspection, quality audits, suppliers’ audits, prevention of cross-contamination and bacterial contamination during production, training employees and personnel.

This comes at a time when seven drug companies in India with substantial exposure to the US market, have also disclosed over the last couple of months that some of their manufacturing facility inspections had reached successful closure, signaling resumption of supplies and new product filings to the US.

Four GMP compliance reports were issued to Indian companies in 2015 compared to an average of around eight in 2011 to 2014. Thirty per cent of quality related warning letters and less than five per cent drug recalls have also been attributed to Indian companies, according to official sources.   

Maharashtra FDA had also recently issued show cause notice to a Nashik based firm for not complying to quality control protocols and good manufacturing practices (GMPs). It was found during inspection that quality control officers were absent in the second and third shift and that explosive solvents like lsopropyl alcohol were stored in open space among other violations.

The firm is a WHO-GMP certified unit and is leading exporter to several countries.

Show cause notice was served for contravening the provisions of Section 18 (c) Rule 74, 78(p) of the D&C Act and various provisions of Schedule M Part I and Schedule Ll.

Based on FDA inspection, it was also found that the firm had not provided separate sampling area for active raw materials and excipients. Other major contraventions included log book for equipment were not in place, hygrometers did not have water, environmental control were not validated periodically, vendor validation records were not produced during inspection, air condition and lights were not found in working condition, no temperature and humidity records were available, overhead and underground water tanks were not cleaned periodically.
 
Even as the Central Drugs Standard Control Organisation (CDSCO) is in the process of upgrading its GMP standards to meet the requirements of global regulatory markets, Form 483s issued last year to Indian manufacturing units had a high level of data integrity issues, pinpoint regulatory experts analysing the trends.

The originality of the data was not ensured and maintained which according to experts has led to data integrity issues which ought to be done on a real time basis. This has led to falsification of data and manipulations.

Regulators globally during their audit visits at Indian sites have issued in total 19 Form 483 last year as a part of their observations on data integrity with the latest made on March 3, 2016 on a leading Indian company.

Several Indian drug makers have come under the scanner of the global drug regulatory authorities in the recent years over a range of issues like data integrity, including production quality, sanitation standards and alleged data manipulation.