The Central Drugs Standard Control Organization (CDSCO), the national regulatory body governing pharmaceuticals and medical devices in India, issued draft guidelines earlier this year designed to ensure the quality and identity of pharmaceutical products throughout the distribution process.
According to the draft document, these guidelines are applicable to all individuals and organizations involved in any aspect of the storage and/or distribution of pharmaceutical products, beginning with the manufacturer and ending with those responsible for dispensing pharmaceutical products to the patient. Parties impacted by the guidelines include manufacturers of bulk or finished products, wholesalers, distributors, logistics providers, transport companies and forwarding agents, among others.
The new controls are intended to prevent the introduction of counterfeit, adulterated, or otherwise sub-standard drugs into the distribution chain and to protect the integrity of legitimate pharmaceuticals through collective adherence to Good Distribution Practice (GDP). Once implemented, these guidelines will strengthen India’s image as a compliant, reliable producer and distributor of quality pharmaceuticals and ensure that product can be verified by Indian regulators at any point within the supply chain.
Regulations cover a broad range of issues and activities that are intrinsic to a validated supply chain:
- Appropriate organization and management of suppliers
- Personnel and training
- Quality systems and self-inspection in keeping with ISO or other accepted national or international guidelines
- Warehousing and storage
- Temperature control of both products and the storage environment
- Inventory control
- Transportation
- Dispatch and receipt of goods
- Documentation and record-keeping
- Complaint mechanisms
- Recalls and returns
- Counterfeit pharmaceutical products
- Importation
- Contractual obligations
While the introduction of GDP guidelines has generally been applauded, the implementation of these regulations and the inspection and verification of suppliers, processes and product is seen as a challenge. Similarly, upgrading the in-country storage infrastructure to an acceptable level to accommodate cold chain requirements and mandatory compliance of GDP may be a lengthier process that needs to be phased in.
At least one organization, PharmaCare Foundation, a Chennai-based registered trust dedicated to educating the public on the safe use of drugs and to encouraging ethical trade practices, has asked the government for a 60-day extension to study and comment on the draft guidelines.
"Considering the present level of pharmacy and distribution practices prevailing in the country, proper storage and handling of drugs is a matter of serious concern," said managing trustee, R Srinivasan. "We have a large number of pharmaceutical wholesalers and retailers, but we face a shortage of qualified and competent personnel to handle all the stages of the drug delivery system. Besides, the infrastructure facilities required to follow the norms of GDP are also poor."