e-governance in the drug administration is all set to get a boost with the Planning Commission endorsing the plans to inter-connect all licensing and registration offices and laboratories for a better functioning of the regulatory authority.
“e-Governance systems that inter-connect all licensing and registration offices and laboratories, GPS based sample collection systems and online applications for licensing would be introduced. A repository of approved formulations at both State and national levels would be developed. The drug administration system would build capacity in training, and encourage self regulation,” said the Planning Commission in its plan document for the current Five Year Plan.
The Planning Commission also recommended amendment to the Drugs and Cosmetics Act (D&C Act) to include medical devices incorporating provisions for their risk-based classification, clinical trials, conformity assessments and penalties.
“The Ministry of Health and Family Welfare would ensure that irrational Fixed Dose Combinations (FDCs) and hazardous drugs are weeded out in a time bound manner. Pharmacovigilance, post-marketing surveillance, adverse drug response monitoring, quality control, testing and re-evaluation of registered products would be accorded priority under drug regulation,” it said.
“The use of generic names or the International Non-proprietary Name (INN) would be made compulsory and encouraged at all stages of Government procurement, distribution, prescription and use, as it contributes to a sound system of procurement and distribution, drug information and rational use at every level of the healthcare system. Established brand manufacturers would be encouraged to bid for Government procurement, but should provide medicines in non-propriety names,” the document said.
“Strengthening of existing, and creation of new drug testing laboratories is essential to ensure the quality of drugs being produced in India, whether they are used for domestic distribution or for export to other countries,” according to the Commission.