Players in the pharmaceutical domain are pressured by statutory and regulatory authority to comply with norms and ensure their supply chain partners are away from threats to their operating markets.
Increasing counterfeit Instances, companies not following basic compliance, entities didn’t “File-Update-Renew” their compliance timely, compliance related to warehouse and safety and audits of regulatory authority & consumer forum (District and regional).
Empliance helps Manufacturer traverse the landscape of compliance regulatory requirements by comprehensive solution of ongoing compliance monitoring of complex third party networks which aids in minimizing Reputation risk and maximize Equity of Pharmaceutical Manufacturers.
Monitoring key compliance of the distributor C&F agent, like working with government entities, drug license, registration license, shop and warehouse license, VAT, CST, ITR, ESIC, EPF, Insurance, Fire & Safety, and Process orientation, adherence to standard operating procedures checked along with Code of conduct and ethics policy.
CLIENT – One of the leading pharmaceutical and life sciences firm
QUERY – Compliance Screening done for their distributors once in 3 years along with distributor agreement renewal. Some media articles were published about counterfeit medicines and these distributors’ names were published. This indicated reputational, operational & supply chain risk in our client’s portfolio during that period and our client had faced discrepancies from their stakeholders. They understood these instances would be harmful to their long term business plans and compliance monitoring would be the best solution to enact upon the same.
SOLUTION – Post media article our client approached us to monitor all business partners with the view of ongoing monitoring of the third parties associated with them, periodic overview was prepared to monitor Regulatory compliance, Statutory compliance, Cover reputation & Operation risk.
Also monitoring and setting up a reminder mechanism for annual and key compliances like (drug license, registration license, shop and warehouse license, VAT, CST, ITR, ESIC, EPF, Insurance adequacy, fire & safety, and process oriented along with procedures & policies). Compliance checks conducted on the entity to spot critical legal risk and red indicators in client’s portfolio.
FINDING – Post execution we found 39% of the entities didn’t follow basic compliance. Around 31% of the entities didn’t file/update/renew their compliance timely. Half the entities didn’t follow compliance related to warehouse and safety. Around 12% of the entire distribution set up had cases in respective high courts and regional consumer forum.
RESULT – Over a period of 6 months the client had hold over their business partners and could curb and change way they previously conducted business with compliant and non-compliant entities. Also periodic review meetings were conducted to understand client portfolio and mitigate compliance, legal and reputational risk.