India has highest number of US FDA approved manufacturing facilities outside the US and yet the Indian pharma industry faces issues of ‘Not of Standard Quality (NSQ) drugs too often. These issues have affected the reputation of the Indian pharma industry adversely. Globally, the image of the Indian pharma industry is getting blurred due to various reason. Hence, the Department of Health, Ministry of Health and Family Welfare has decided to redefine ‘Not of Standard Quality’ drugs and proposed certain changes in Section 36AC. The industry and associations share their views on the changes proposed and their potential impact. By Usha Sharma
‘Clear definition of NSQ will give protection to genuine manufacturers of quality drugs’
The Indian legal system is often fraught with laws which are not adequately thought through and drafted ambiguously, resulting in unintended consequences in spite of good intentions. The matter is often compounded due to the judicial process moving at a snail’s pace. While Indian pharma industry has made phenomenal progress in the past couple of decades and has earned the distinction of being the ‘Pharmacy to the World’, regulatory agencies in the country have not been able to keep pace with this progress. The Drugs Act (Amendment) 2008 defines only three categories of Drugs under section 36AC viz. spurious, misbranded and adulterated. The lack of proper definition for ‘Not of Standard Quality’ (NSQ) drugs often results in genuine and licensed manufacturers getting penalised under the above three categories. Quite often a standard quality drug manufactured by a licensed manufacturer fails in potency or physical appearance (discoloration, chipped tablets etc. ) due to improper storage or a poor supply chain during distribution.
For instance, it is not uncommon to see a truck carrying thermolabile medicines like multivitamin or antibiotic preparations getting stuck in the hot Indian sun for hours at a toll or octroi booth, resulting in some loss in potency. Imported drugs requiring cold chain often lie on the airport tarmac for hours before being transferred to the cold warehouse, thereby causing break in the cold chain. Also load shedding or power failures often expose thermolabile drugs to high temperatures. Such drugs cannot be classified under the three categories or NSQ drugs, resulting in severe punishment to the good manufacturers. One may argue that such issues should be taken care of while conducting accelerated stability studies during formulation development. However, shelf life study is quite a complex matter and such studies cannot fully predict formulation behaviour during its shelf life. Similarly, barring few exceptions, FDA testing labs in most states suffer from lack of trained analysts, modern analytical instrumentation, proper funding, validation of analytical methods etc. In fact, Mashelkar Committee Report, in 2003, made scathing remarks on the functioning of such labs. Unfortunately, the situation has only marginally improved since then. These labs are very rarely audited by independent authorities for GLP. However, punishment to licensed manufacturers is often based on the analytical reports given by such labs. While producers of spurious, misbranded or adulterated drugs should be severely punished and heavy penalties should be slapped on them, a genuine manufacturer should not be penalised for ‘unintended consequences’ due to ambiguous definition of NSQ.
Clear definition of NSQ will give protection to genuine manufacturers of quality drugs from unnecessary harassment and loss of reputation due to factors beyond their control.
– Ajit Dangi, President and Chief Executive Officer, Danssen Consulting
‘It is imperative to align the definition of NSQ with the expectations of US FDA’
Establishing regulatory standards is critical in the pharma industry. Regulatory standards help the industry consistently perform and ensure reliable enforcement by regulators. As part of regulatory standards, definitions and terms must be interpreted and applied uniformly throughout the global marketplace. To enable regulatory compliance, it is imperative to align the definition of NSQ with the expectations of US Food & Drug Administration and other world regulators. The Indian Drug Manufacturing Association (IDMA) should harmonise with globally recognised regulatory definitions to ensure standards in a global marketplace.
Drug stability has always been a critical product parameter. If products are developed properly and manufacturing processes are validated appropriately, then assurance of drug shelf life should be a natural result. While it may be a complex technical issue for many drugs, it remains an expectation of the user/ patient that the drug’s potency and therapeutic value will be consistent throughout its labelled shelf life. If a manufacturer has evidence that it is not, then the only recourse is to remove the product from the marketplace. This is the expectation of all regulators. The definition of NSQ should include the requirement that the manufacturer has proven its potency across its full claimed shelf life.
– Bob Rhoades, Vice President, Quality and Compliance Services, Quintiles
Regulator and industry should jointly address quality issues
Change in definitions do not build the image of an industry. The regulator and the industry need to work hard and jointly to address quality issues. The image of the industry is directly linked to the quality and competence of the regulator also. The industry needs to focus on the real issues.
– DG Shah, Secretary General, Indian Pharmaceutical Alliance (IPA)
‘It is necessary to have clear distinction of the terms/ activities, with respect to Section 36AC’
Section 36AC of the Act deals with offences to be cognizable and non-bailable in certain cases. Under this section, offences relating to adulterated or spurious drugs are only cognizable and non-bailable. However, ‘not of standard Quality’ drugs which may be adulterated or spurious are treated separately. With a view to safeguard and to protect the genuine manufacturers from rigid penal actions provided under this section and to ensure deterrent punishment to scrupulous dealers, it is necessary to have clear distinction of these terms/ activities, with respect to Section 36AC.
This step will build confidence in the Indian industry and show the rigid intent of the Indian Government against adulterated or spurious drug manufacturers or dealers. It will enhance the image of the Indian regulatory system in protecting public health.
It is true that manufacturing and ensuring stability of drugs till shelf-life of product is a complex issue and highly technical. Regarding change in NSQ drugs, we observe that the Government has not proposed any change in the definition of NSQ drugs but proposed to classify the ‘not of standard quality’ drugs into various categories. We believe that such categorisation would enable the Government to assess the seriousness of the violation within the group of ‘not of standard quality’ drugs for imposing appropriate penalties depending upon the seriousness of violation. This is also likely to enable the Government to give severe punishment to those who violated by manufacturing NSQ drugs, where safety and efficacy of the drug is adversely effected significantly. Therefore, this approach is desirable.
– Dr PV Appaji, Director General, Pharmexcil
‘The definition of an NSQ drug has nothing to do with the stability and shelf life of drugs’
If proper definition of ‘not of standard quality’ drugs is not made in the Drugs & Cosmetics Act, there is a possibility of some of the NSQ drugs being interpreted as spurious and adulterated drugs, which will mar the reputation of the genuine pharma manufacturers and provide them penal punishments and jail. For example, if the assay of the drug is not complying with the specifications, the drug can not be considered as spurious. It may be a case of analytical error or poor storage conditions, etc. It does not mean that there is a substitution of the drug.
In the absence of a proper definition of NSQ drugs, the world community tends to mix up the same with other serious categories like adulterated and spurious drugs and thereby label India as a country making spurious drugs.
This misconception of the world community can be dispelled. The definition of an NSQ drug has nothing to do with the stability and shelf life of drugs. It is the manufacturers’ responsibility to provide safe and effective drug to benefit the patient. There will be no changes with respect to standards, processes and expectations for providing quality drugs. The definition of NSQ drug is only to differentiate the same from spurious drugs.
– SV Veerramani, President, IDMA
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