Since next to food, drug is essential and a life saving product, special care and importance must be given to the production and distribution of drugs by the pharmaceutical industry. Hence the drug companies and pharmaceutical trade have to adhere to prescribed rules, standards and business ethics while manufacturing and marketing pharma products as they directly affect the public health, say experts in the field.
As Good Manufacturing Practices (GMPs) help to bring a new level of quality and accountability to the pharma industry, nations like China and Vietnam are fast taking measures to improve compliance levels. Ministry of Economic Affairs (MOEA) officials in China has said that to ensure food safety, the ministry plans to make GMP audits mandatory for local food additive manufacturers, importers and exporters.
The New GMP raises GMP standards in China, placing more emphasis on the operation of an effective quality control system by pharmaceutical companies. The main changes in the New GMP include strengthening the establishment of a drug manufacturing quality management system; bolstering overall employee quality requirements; refining document management rules such as standard operating procedures (SOPs) and manufacturing records and introducing the concept of quality risk management.
The new rules also include new processes and measures for supplier audits, change control, new approaches for procurement of excipients and other raw materials, and other measures designed to help prevent and correct quality failures.
Newly established drug manufacturing units, and renovations or expansions of manufacturing facilities by existing drug manufacturing sites will have to comply with the new GMP immediately. However, existing manufacturing facilities have a transition period to come into compliance.
Those manufacturing sterile drug products such as blood products, vaccines and other injectable drug products will be required to comply by 31 December, 2013, while all other facilities will have until 31 December, 2015.
China’s State Federal Drug Administration (SFDA) is now all set to issue a set of stringent norms to clamp down poor quality standards in drug production. It has also released a guidance on the on effective utilization of adverse drug reaction (ADR) monitoring data. The notice requires to make effective analysis, evaluation and utilization of ADR monitoring data, enhance the responsibility awareness and risk awareness of manufacturing enterprises and further strengthen daily management of ADR monitoring. Further, it has also defined time limits for ophthalmic preparations and related products to meet the requirements of newly revised GMP.
All pharmaceutical companies in Vietnam, using natural ingredients in the production of their products, are required to meet the World Health Organisation's GMP standard by January 1, 2014 in order to continue operations, according to the Ministry of Heath.
To date, around 100 companies, more than 50 per cent of the total number of pharmaceutical companies operating in Viet Nam, have met GMP standards which cover the manufacture and testing of pharmaceutical drugs, requiring manufacturers to ensure that their medicine and related products are safe, pure and effective.
The Ministry of Health has required pharmaceutical companies who produce western medicine to follow GMP standards since July 1, 2008 and to apply for business licenses in order to produce drugs.
The Ministry aims at improving the standard of domestic pharmaceutical production in order to meet international standards and to promote the export of Vietnamese medicine
GMP requires the pharma companies to manufacture products by maintaining prescribed standards with effective and coordinated use of personnel, land building and equipments in sanitary and clean premises. All the activities pertaining to manufacture have to be performed in a dedicated manner prescribed under regulations. Manufacturers of drugs must realize that adopting GMP is their responsibility, according to an expert.
He said that it was also the responsibility of the Government to ensure that drugs supplied to the public are of good quality and should be made in a facility conforming to GMP. While controlling the various activities of the pharmaceutical industry with an object of circulation of quality drugs, the government should give due importance to the pharma industry because it is making a steady progress in the country. Government should ensure the drugs’ purity and effectiveness, but the control must be at all the stages of production, he said.
At the same time upgrading facilities according to the WHO-GMP and Indian GMP standards needs liberal funding from the government and some financial incentives, but without so many restrictions feel Small and Medium Enterprises (SMEs).
SMEs are looking to the government for support on technology upgrade in manufacturing, brand promotion and marketing, to perform better in the domestic and export markets. Marketing and regulatory constraints are putting pressure on SMEs, said a spokesperson of the pharma manufacturers’ association.
The opportunity is mainly in contract manufacturing, for both MNCs operating in India and Indian companies, which are looking to outsource manufacturing activities for the domestic market and focus on exports to regulated markets like the US and Europe.
But SMEs first have to upgrade their capabilities to comply with manufacturing standards like Good Manufacturing Practices (GMPs) set by the Indian government and the WHO. For this, they need financial support from the government, he added.
“Upgrading facilities according to the WHO-GMP and Indian GMP standards needs liberal funding from the government and some financial incentives, but without so many restrictions,” he adds.
GMP refers to the Good Manufacturing Practice Regulations issued by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act. Through this they have created legal guidelines and regulations that require manufacturers, processors, and packagers of dietary supplements to take proactive steps to ensure that their products are safe, pure, and accurately labelled. GMP regulations also require implementation of a standardized systematic approach to manufacturing that requires nutritional supplement companies to minimize or eliminate instances of contamination, mix-ups and other errors. The intention here is that these good manufacturing practices will protect consumers from potentially dangerous products. The failure of manufacturers to comply with GMP regulations can result in very serious consequences including product recall, seizure, fines, and jail time.
GMP regulations also address all kinds of company infrastructure issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls specific to their company. This provides for a lot of flexibility and allows the individual manufacturer to interpret the requirements in a manner that makes sense for each unique business model.
After much dithering, India started enforcing cGMP standards for pharma industry in the second half of the year 2005. And, a few hiccups cGMP regulations were put on hold at least thrice as India’s pharma industry demanded more time to comply with the new set of manufacturing standards.
However there are still lacunae that need to be overcome, especially for the long-time survival of small scale industries (SSIs); both for producers of drugs as well as pharmaceutical machinery. It’s been five years since the implementation of cGMP regulations in India, and still, thousands of SSIs or small and medium enterprises (SMEs) of India’s unorganized pharma industry have not complied to these preventive regulations put in place by the US Food and Drug Administration (FDA) and followed as guidelines across the globe today.
While most have shown resistance and have been demanding for more relaxations in the cGMP compliance list, others are simply unaware of the repercussions, thus making it necessary for more training and research to ensure continual compliance of cGMP, which assure quality, proper design, monitoring, and control of manufacturing processes and facilities.
While the harmonization of GMP and Schedule M has not been accepted by the small players in the Indian pharma industry, the big players seemed to welcome the harmonization as it adds credibility to their products and thus increase their sales and production. Aside from meeting local GMP requirements, it helps them to gain more acceptance in the import-export market.
Though GMP harmonization with Schedule M may be a challenge in the early implementation stage but if viewed from the bigger picture, it is a win-win situation for both India’s pharma companies and for the consumers.
If a company is GMP certified it will enhance its credibility in the market, it is tantamount to the fact their products are of good quality and can be trusted. Trustworthiness of a product will lead to increased sales. As far as the consumers are concerned , this means that they will get safe, quality and effective products.
GMP compliance will help Indian pharma companies to scale newer peaks . It would help to enhance the pharmaceutical industry practices and enable them to become world class players on the international arena.