The Centre should scale up the production of active ingredients used in drugs to meet the country's need, a government institute has said after it found that over 95 per cent of the samples examined during a survey were sourced from China.
The Centre should scale up the production of active ingredients used in drugs to meet the country’s need, a government institute has said after it found that over 95 per cent of the samples examined during a survey were sourced from China. The Noida-based National Institute of Biologicals (NIB), outlining the findings of the country’s largest ever drug quality survey, has said that over 90 per cent of nearly 5,000 samples picked up from airports and seaports were from China.
The NIB, an autonomous organisation under the Ministry of Health and Family Welfare, has also asked the government to consider setting up a training academy in drug regulatory sciences to create skilled manpower which will help realise the objective of India becoming the ‘pharmacy of the world’.
The drug survey had found that over 10 per cent of drugs in the government supply chain were ‘Not of Standard Quality’. “In the drug survey over a period of three months, 4,987 samples were drawn at the airports and seaports. It was observed that 98.51 per cent of these samples were that of Active Pharmaceutical Ingredients (APIs) of which 91.87 per cent were from China. “One company from China alone accounted for 26.82 per cent of APIs imported into our country,” it said.
In light of these facts, it is imperative that the government may take measures to scale up existing indigenous production capacity of APIs and set up new manufacturing units to enhance production to meet the country’s need, the body said in its recommendation. It also asked the government to create a national digital database of all distributors, retailers, pharmacies, government sources, name and contact information of licenced pharmacists which should be regularly updated.
The institute argued that continued training is “critical” to ensure that drug regulators remain proficient in their operational functions and in their understanding of current good manufacturing practices, good laboratory practices and good distribution practices. “The National Training Academy should institutionalise training of drug regulators, both new recruits and in-service officials, to enhance their depth and width of regulatory know-how, skill and competence in various areas of drug regulation, enforcement and data integrity.
“The training should be conducted by experienced faculty on a regular basis and participants should be subjected to pre and post-training assessments including behavioural aspects and skill development,” it said. It said modern digital technology tools should be leveraged to achieve these objectives and to integrate all stakeholders in the system to create a ‘National Regulatory Knowledge Sharing Platform’ to bring transparency, accountability and traceability in the drug supply chain management throughout the country.
During the survey, over 10 per cent of drugs in the government supply chain were found to be ‘Not of Standard Quality’ (NSQ).
In comparison, the estimated percentage of NSQ drugs from samples taken from retail outlets across the country was three per cent while 0.023 per cent were found to be spurious.
The extent of NSQ and spurious drugs for both retail outlets as well as government sources in the country together was estimated to be 3.16 per cent and 0.0245 per cent respectively, the survey found.
The statistical design of the drug survey included as many as 224 drug molecules belonging to 15 different therapeutic categories of the National List of Essential Medicines (NLEM) 2011.
As part of this survey, 47,954 drug samples relating to 23 dosage forms were drawn from 654 districts of 36 states and Union territories from the supply chains including retail outlets, government sources and from eight airports and seaports.