The central drugs control establishment has initiated steps to facilitate the creation of dedicated pharma zones at the airports and sea ports, by conceptualizing facilities and taking inputs from the stakeholders with a view to extend maximum assistance to the industry.
Separate dedicated and controlled environment, pharma zones, will be set up within the cargo premises at airports and sea ports for proper storage of pharmaceutical products in line with Good Manufacturing Practices and Good Distribution Practices so as to assure the quality, safety and efficacy of drugs/pharma products meant for import/export. DCGI office has prepared a detailed project report including layouts for such pharma zones and placed for comments from the stakeholders, sources said.
Pharma cargo zones will come up at the airports of Delhi, Hyderabad and Mumbai. Besides, another cargo zone will come up at Nhava Sheva port at Navi Mumbai. The DCGI office also has initiated consultations with the airport developers and the civil aviation ministry in this regard.
According to the detailed project report prepared by Assistant Drug Controller at Delhi international airport Sunil M Joshi, the zone will have cold room facility to maintain varied temperature (-20, +2-8 degree centigrade), comfort zone having temperature below 25'C for examination, storage in bonded area, humidity control to prevent moisture damage in summer and freeze in winter, sampling dispensing area and basic testing facility, office for ADC and other regulatory authorities, palletisation area to ensure preparation of pallets in the cool chain facility, fixed location system for different dosage forms, and provision to keep narcotics separately.
At present there are no facilities with specific temperature and atmospheric controls and the exports and imports are constrained by infrastructure bottlenecks. There is also no temperature controlled area for life saving drugs and vaccines. Non-drug and drug items are stored together, leading to degradation and contamination of drugs in the airports and sea ports. Besides, there are no competent staff for handling pharma products, according to the project report which was prepared based on existing trends, potentials, difficulties in the area.