The UK drug regulator's recently updated statement of non-compliance has included all active substances manufactured at Wockhardt's Chikalthana facility following the company's decision to end supply of active pharmaceutical ingredients (APIs) to the European Union (EU) markets.
The UK drug regulator's recently updated statement of non-compliance has included all active substances manufactured at Wockhardt's Chikalthana facility following the company's decision to end supply of active pharmaceutical ingredients (APIs) to the European Union (EU) markets.
However, an initial statement of serious non-compliance (SNC) permitted continuation of supply of critical API from the Chikalthana facility.
The drug regulator Medicines and Healthcare Products Regulatory Agency (MHRA) in an email response to dna clarified that while the original SNC did allow the supply of APIs for products regarded as critical, the updated SNC does not. The change is specific to the APIs manufactured at Chikalthana in Aurangabad.
"The initial statement of serious non-compliance permitted continued supply of critical APIs. Following a company decision to cease supply of API to the EU market, this statement of non-compliance was updated to cover all active substances in January 2015," MHRA said in its recent notification on the EudraGMDP database. EudraGMDP is hosted by EMA on behalf of the EU Member States.
The British drug regulatory agency further said that re-inspection by an EU national, competent authority will be required prior to gaining approval to restart supply to the EU market in future.
While no recall action was proposed, the agency said that marketing authorisation holders should be requested to remove the site from applicable authorisations by variation.
A request for comment emailed to the company did not elicit any response.
Talking about the nature of non-compliance, MHRA listed a number of deviations. The agency, which conducted an inspection of the facility in November 2013, said that it does not comply with the good manufacturing practice (GMP) requirements.
"A critical deficiency was cited with regards to data integrity of GMP records, entries were seen to be made when personnel were not present on site, documentation was seen that was not completed contemporaneously despite appearing to be completed in this manner," the agency said, adding that a second critical deficiency was cited regarding potential product contamination, this included the use of inappropriate materials close to product e.g. asbestos coated PTFE seals for centrifuge manways.
According to MHRA, a major deficiency was cited with regards to equipment and facility, maintenance, design and qualification.
"Examples included, inappropriate pressure differentials that were not in line with the original design but had not been changed using change control, cleaning validation that was not sufficiently robust to confirm cleaning practices and maintenance issues, such as the failure to spark test glass lined reactor vessels for integrity especially following maintenance," it added.
The regulator said that the site manufactures high blood pressure medicines Captopril, Oxybutynin HCI which is used to treat certain bladder and urinary conditions and Pramipexole Dihydrochloride monohydrate used to treat Parkinson's disease.
The Mumbai-based drugmaker is tackling a number of regulatory issues with the foreign regulators. In 2013, the US drug regulator Food and Drug Administration (FDA) issued an import alert on the company's two facilities, Waluj and Chikalthana, both in Aurangabad. MHRA also withdrew its quality certification to the Chikalthana plant in 2013 after it identified deviations in the facility. However, the agency later issued a restricted GMP which is still in place.
"The restrictions on dosage forms manufactured at Chikalthana remain unaltered. The SNC for the API site means that APIs produced there cannot be used for EU products," MHRA said in the email response.
Meanwhile, a number of other Indian companies have also been banned to market certain drugs in EU by a number of European drug regulator. While the Italian Medicines Agency withdrew the GMP certificate from Hyderabad unit of Sri Krishna Pharmaceuticals, French National Agency for Medicines and Health Products Safety maintained its statement of non-compliance on Medreich's Bollaram facility at Andhra Pradesh.
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