India's Central Drugs Standard Control Organization is sending staff to drug manufacturing hubs across the country to train workers in good manufacturing practice (GMP) in a multiyear program it hopes will get to the root of problems in record keeping and quality control highlighted by regulators abroad.
“It is high time that we put proper practices and regulation in place for the pharma industry. India has one of the biggest generic industries in the world, and we need to ensure the quality of medicines produced here,” G.N. Singh, the Drugs Controller General of India, who heads CDSCO, told the Live Mint newspaper.
Singh said the plan is to share knowledge across the factory floor in order to cement the lessons learned.
“We will visit Baddi (Himachal Pradesh state) in last week of May and train officials from 5 manufacturing units," he told the newspaper. "They will then be encouraged to share that knowledge with employees of other units."
India has several hubs for drug manufacture near the financial and manufacturing centers of Mumbai in Maharashtra and Ahmedabad in Gujarat. Hubs are also in Hyderabad in southern India and in the northern state of Himachal Pradesh.
The industry contributes an estimated $15 billion in drug exports--marking it as the world's top generic producer.
But it has faced repeated regulatory knocks from the U.S. FDA and European regulators over the past several years for falsifying records and lax sanitary enforcement in manufacture--all of which has led to the suspension of shipments to Europe in one case and import bans on scores of plants that send products to the U.S.
The bans have prompted other plants to improve quality, including mulling membership in the Pharmaceuticals Inspection Cooperation Scheme (PIC/S) to raise standards.
Live Mint also said the domestic lobby group for generic firms, the Indian Pharmaceutical Alliance (IPA), announced that it is in the process of outlining "data integrity guidelines" for companies cited for lapses.
One reason for the coordinated federal push, Live Mint said, is that manufacturing in India is regulated at the state level, resulting in varied standards.
“Right now, most of the people engaged in manufacturing are not even aware of national and international standards of manufacturing. They do not know how to produce quality medicines. That is one reason why sub-standard medicines get manufactured. Even the records are not maintained properly,” Singh told the newspaper.
- here's the story from Live Mint