The biggest problem the industry faces is vague qualitative narration of cGMPs of various regulatory bodies, which leaves interpretation of the statements to the individual inspectors. The language must be mathematical English, which cannot be interpreted differently by different individuals. Unfortunately, neither the various cGMP demands are same nor the narration very clear, Sugato Majumdar, director-operations, Trans Tech Turnkey, Pune said.
Another critical aspect with regard to cGMP compliance is that small and medium pharma companies cannot attract and retain quality manpower in either engineering or production or QA, and they, for reasons of economy, depend on consultants who themselves are not aware of cGMP needs, hence their half measures can never ensure total compliance.
He added, moreover, we must admit our ethical values are not the same, hence more often than not, even after creating a reasonably good facility, compliance is sacrificed for the greed to make more money and contamination control measures (which does gulp substantial energy) are only put in operation when there is a regulatory visit or inspectors from large manufacturers for whom they do third party manufacturing, visit the plant. "This must stop for the sake of humanity & compliance to cGMP must become a culture which we believe and practice", he said.
"Without complying with GMP, in ideal situation, one cannot carry on with manufacturing, without resorting to corrupt means. Making a drug non-compliant and getting away by corrupt means can harm precious human lives. Hence, he said, success without adopting corrupt means, by non-compliance of GMP is impossible. If corruption is uprooted, companies which do not comply with GMP will be forced to close down", he added.
Quite a few Indian companies produce drugs by maintaining much better standards than quite few companies in so-called developed nations. "However some small players and quite a few large Indian manufacturers are producing drugs in an environment, which is horrific. Antibiotics and diazepam are produced in two compression machines kept in the same room and for some in sterile filling area terminal filters drip condensed water," he added.
2005 and beyond opens up an opportunity beyond comparison for Indian Drug makers, but as already stated, a uniform standard cGMP applicable to all the countries is a dream, which we all are hoping for. Whatever we produce and wherever we want to sell, if we are to succeed in the long run compliance to cGMP must become a culture for each and every employee.
Talking about his company, Majumdar mentioned that Trans Tech Turnkey is involved in design and building facilities for environmental control as per pharma and biotech industries' requirements. It has designed, installed and validated numerous plants for now Sandoz, erstwhile Novartis, the second largest drug maker in the world.