In the wake of import alerts and warning letters from international regulatory agencies citing alleged poor compliance at the manufacturing sites in the past, Maharashtra Food and Drug Administration (FDA) has recently concluded an inspection drive of 60 units from around 240 WHO- GMP certified units from across the state to ascertain compliance and quality.

The drive according to FDA officials was based on randomised checking schedule to ascertain that the export oriented units follow compliance to Schedule M based on parameters like documentation, testing, quality, validation and SOPs.

The state FDA had embarked on a surprise inspection spree on these units in the state, which the industry terms as 'unnecessary and without any logic' as these units were issued the WHO certification after a joint inspection by CDSCO and state FDA.      

Maintains an FDA official, "Units were inspected in Raigad, Thane, Nashik, Pune, Aurangabad, Nagpur and Mumbai for Schedule M compliance, more so, as these units are export oriented. The inspection report on these units is in the process of getting prepared by respective drug inspectors."

The inspections are meant to detect compliance level of good manufacturing practices (GMP) by the units. Based on the randomized checking schedule chalked out by the FDA Commissioner Purshottam Bhapkar, the official explains, units were inspected by a dedicated group of thirty teams of drug inspectors. One team comprised of two drug inspectors which were supervised by an assistant commissioner.  

Last December, the FDA instituted a three-member Special Investigation Team (SIT) comprising drug inspectors from Ahmednagar, Solapur and Mumbai to inspect pharma plants on GMP compliance following a US FDA ban on export of medicines from the three Indian based plants to American markets after its investigators submitted reports citing alleged malpractice there.

US FDA also conducted a series of workshops in May, 2014 to equip leading Indian pharma companies on maximising compliances related to consent decree, Form 483, data integrity and quality management systems.

Notices were issued to a leading pharma company's three plants in Aurangabad and an explanation was sought on poor compliance with good manufacturing practices.

The state FDA in its inspection found biomedical waste lying unattended outside the plants in Maharashtra. Biomedical waste dumped openly, rusted drums containing glycerine used in making injections lying unused, proliferation of insects, rodent excreta and storage of raw material in rusted barrels.

The special team constituted by FDA made appalling discoveries in the plants which violate the Drugs and Cosmetics Act, 1940. Sources said the team noticed the absence of a scrap yard to dump industrial waste. It was found during the inspections that up to 114 rusted drums containing glycerine, used in making injections, were lying outside the plants. Also, 5,000 vials of Agar gel, which is used as media for culture in injections, was lying in the open. It is an ideal breeding ground for the uncontrolled growth of microorganisms, threatening contamination of the atmosphere.

The team further noted that the company had not made separate provisions for storage of hazardous material hydrochloric acid, glacial acetic acid, ammonia and acetonitrile.

Medicines from the Indian plants are exported across Russian, Middle East and European markets. Over 40 per cent of the medicines being produced in Indian plants are exported abroad.