Recent Chhattisgarh Sterilization Tragedy is heart-wrenching. More than 15 women are dead and numerous critical after the mass sterilization programme held by the Chhattisgarh government. Reports suggest, nearly 80 women attended the free government-run camp in the central state of Chhattisgarh on to undergo laparoscopic tubectomies, usually a straightforward surgical procedure.
Probable reason: Antibiotics used in the process were possibly contaminated by the rat poison chemical.
Such tragedies due to medicinal negligence had been a part of history since long and the sad part is: they are still prevalent. This is not a case in isolation for India. Even the big names like Ranbaxy and Sun Pharma have been warned by FDA banning few of their products. FDA is considering regulatory negligence in India seriously and as a result, the export is strictly under the scanner. This has put industry big names, specialists, researchers, and analysts in deep introspection. A conference was recently held in Indore jointly by “IPA and Pharmexcil” on November 7th, 2014 to focus on the challenges facing Pharma Industry and their probable solutions.
Why such events occur?
Negligence and non-compliance on the part of manufacturers can be tagged as the major reasons:
- Lack of proper facilities and machinery with no emphasis on mandatory adoption of current Good Manufacturing Practices (cGMPs)
- Absence of proper system in place for advanced Quality Control and Assurance to check the purity and strength of medicines
- Non-conformance and improper documentation are other factors that result in such incidences
The onset of a better tomorrow
It is realized by industry specialist that an ERP built specifically for Pharma Industry can be a savior for manufacturers who want to keep their brand names away from being linked with such unfortunate events. Realizing this BatchMaster has come up with a tailored solution for the Pharma industry. This solution “BMM SAP B1 for Pharmaceuticals (BMM B1 for Pharmaceuticals)” from BatchMaster software is built on the strong foundation of SAP Business One. BMM B1 for Pharmaceuticals has been designed to ensure that its pharma customers are able to comply with obligatory cGMP requirements and produce high-quality products. Software solution has the provision of incorporating quality checks at various stages of product manufacturing, quality approval workflows, controlled movements through statuses, sampling plans, and stability testing. Bi-directional traceability, to help in quick recalls with minimum damage. It auto-generates non-conformance for items failing in QC along with CAPA for root cause analysis and corrective/preventive actions.
The Indian pharmacy industry is expected to touch $ 45 Billion by 2020. A sign positive for an economy like India. To salvage the Indian pharma industry and bring it out flourishing, an ERP, one like BatchMaster is essential. It’s not the need of the future but TODAY!