To discuss and understand the issues related to the surprise visits of the WHO certification for schedule M compliance
Pharmexcil along with few pharmaceutical industry associations are likely to meet the Maharashtra State FDA commissioner on December 11, 2014, in order to understand the rationale for the slew of surprise plant visits conducted by the Maharashtra FDA officials over the last week of November, WHO certified manufacturing facilities for schedule M compliance,
Sources have informed Express Pharma that over a period of 6-7 days, the Maharashtra State FDA inspected more than 50 units located in the state for schedule M compliance.
The list of inspected companies include Maneesh Exports, Aurochem, Glenmark Pharma, Aarti Drugs (four plants), Cipla, MJ- Biopharma, Piramal Enterprises, FDC, Ajanta Pharma, Sandoz, Leben Laboratories, Glow Pharma, Polypeptide, LA Pharma, Cupid, Samras Pharma, Genom Pharma, Shreya LifeSceinces, Reliance Life Sciences, Fresenius Kabi, and Bal Pharma. The same sources reveal that a few of these companies received warning letters whereas some were handed letters banning manufacturing activity for alleged non-compliance of GMP norms.
According to industry sources, representatives of the State FDA seem to have identified 250 pharma companies which have been certified by the CDSCO and State FDA authorities. Initially, the inspections were carried out at larger pharma firms, with the current focus moving to mid sized and small sized pharma companies. These sources allege that a few of these facilities received WHO certification almost 15-20 days back.
When Express Pharma contacted the State FDA office to confirm this issue, it was stated that that this was a routine exercise and more information could not be revealed.
Commenting on the inspections, Dr K Bangarurajan, Deputy Drugs Controller, India, Central Drugs Standard Control Organisation said, “This is a state level initiative. We have not received any formal instruction from the centre.”
Each inspection is been conducted over a three-day period by drug inspectors and Assistant commissioners who are from jurisdictions other than that of the company. Even units which have been recently inspected either for WHO or schedule M compliance are been inspected once again.
Sources reasoned that, “We fail to understand the reason for the drive as these units have been cleared by the same department, so if there seems to be any doubt on the certifications given to these units, then it should have been taken up by the CDSCO regarding the validity of WHO approval granted to them. If, the drive has been taken on compliance issues, then logically it should be done across the board and should start with units that are not WHO certified.”
According to Pharmexcil, pharma exports have already taken a dip of six per cent on a Y-O-Y basis and a cabinet secretarial level meeting was called on November 28, 2014 to understand the reasons for the same.
Pharmexcil members also pointed out that these surprise inspections which seem to have to logical purpose, contradict the Prime Minister’s own drive to improve India’s ranking from 144 to the 50th position in the Ease of Doing Business Index which he plans to achieve by April 2015.
Maharashtra and Gujarat constitute almost 50 per cent of the pharma exports revenue and sources opine that the kind of drive initiated by Maharashtra FDA could prove detrimental to any initiative to increase pharma exports from the state.