‘Manufacturers should engage the USFDA early during drug approval for naming of a product’
Tell us about the medicines compendium and its adoption by drug manufacturers?
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| Srini Srinivasan |
The Medicines Compendium (MC) is a free, online resource (www.usp-mc.org) providing public quality standards for medicines approved in any country, including India. Standards in the MC establish an article’s identity, strength, quality and purity and include documentary standards (in the form of monographs and general chapters) and allied reference materials for chemical and biologic medicines and their ingredients.
Monographs contain two components: a performancebased monograph listing quality specifications, and a reference procedure for testing conformance to the specifications. MC monographs are typically referenced general chapters (citing tests, procedures or general information) from USP’s compendia, United States Pharmacopeia and the National Formulary (USP–NF) available on the MC website.
Manufacturers of drugs usually are expected to comply with the official standards of the country in which the drugs are intended for sale (e.g., drugs marketed in India must comply with the Indian Pharmacopoeia). When a destination country’s standard does not exist for a particular product, it may adopt the USP–NF standard (India, Canada, and others) for that product. Adopting countries may indicate other sources for standards, or choose not to apply any standards to products in their marketplace at all. Regulators, industry representatives and other stakeholders in the pharma arena may translate an MC monograph into any language, and may otherwise adopt or adapt the standards, without charge or prior permission from USP.
USP’s standards that appear in USP–NF are specified in the adulteration and misbranding provisions of the US Federal Food, Drug, and Cosmetic Act and are applicable to medicines that are marketed and/or manufactured or imported into the US. However, their enforcement is the responsibility of the USFDA and other government authorities in the US and elsewhere.
What have been the activities of USP in the past one year in India?
In 2011, USP expanded its site in Hyderabad, India. Today, the USP-India site is 12,000 sq m, of which 7,000 is dedicated to laboratory space, making it the second-largest of USP’s sites worldwide with a staff strength of 142 Indian nationals.
Our laboratories are equipped in spectroscopy and separations enable us to play an important role in collaborative testing that support USP–NF as well as MC. For the MC, USP-India is specifically involved in the development of public standards for both chemical and biological medicines. It is also engaged in USP’s Verification Program, conducting testing related to the verification of drug substances, dietary supplements and excipients. while also auditing activities and document reviews for USP’s Verification Programme.
The Indian Pharmacopoeia Commission (IPC) is invited to use any of the monographs published in the MC without cost or need for attribution to USP.
Microbiological control of sterile and non-sterile pharma products is important to ensure the safety of drugs. What is USP doing towards this?
Manufacturers must always consider the extent of microbial contamination in a finished product. USP’s standards address microbial presence and absence in both sterile and non-sterile pharma products. Non-sterile drugs, such as oral dosage forms or topicals allow for the presence of small amounts of microorganisms (low bioburden).
Sterile products, on the other hand, which include parenteral drugs, must be manufactured and handled to avoid any microbial presence, given that they are administered into the bloodstream. Microbial contamination in sterile drugs can cause disease and in some cases, death. While all products marketed in the US that are subject to USP-NF standards and purport to be sterile have to meet the requirements of USP’s General Chapter <71> Sterility Tests or risk being deemed adulterated or misbranded, sterility assurance is gained only through the use of robust and validated sterilisation processes. USP is also developing informational general chapters on distinct processes for sterilisation, how they are to be conducted and what types of materials are suitable for their use.
 “USP is evolving a ‘Reference Procedure’ approach that supports a globally harmonised drug substance and product monograph. We are looking at intense collaboration with Indian stakeholders, including the Indian Pharmacopoeia Commission (IPC), government bodies and Indian manufacturers.”Roger Williams, CEO, USP |
What are some of the alternate and modern microbiological methods that can be used for drug testing and quality verification?
Conventional microbiology tests found in the pharmacopeias, such as sterility tests, rely on the demonstration of microbial growth. However, they have low sensitivity while being time- and labour-intensive in nature. USP is seeking to identify new referee tests or procedures (used by the USFDA or a third party to assess regulatory compliance) based on modern methods that can detect and enumerate microorganisms in a more rapid and sensitive manner. These would include any
validated methods based on technologies that look at phenotypic and/or genotypic microbial characteristics. The USP Microbiology Expert Committee also is updating General Chapter <1223> Validation of Alternative Microbiological Methods to enable users to validate alternate microbiological methods, including those based on modern technologies.
WHO held a meeting last November to promote the prevention and control of substandard/spurious/falsely-labeled/falsified/counterfeit” (SSFFC) medical products. Are there any stringent measures being taken by USP towards this?
USP is developing a suite of general chapters on good distribution practices for drug products; drug substances; excipients; dietary supplements; compounded preparations and other subcategories of compendial articles. These will cover quality management systems; environmental control management; importation and exportation and supply chain integrity—all critical elements in the prevention and control of SSFFC medical products.
USP’s new monograph naming policy is all set to come into effect by May this year. What does this mean for Indian manufacturers?
USP’s new Monograph Naming Policy, which will become official on May 1, 2013, will apply prospectively to drug product and compounded preparation monographs that appear in USP–NF.
According to the new policy, a drug product or compounded preparation formulated with a salt of an acid or base will use the active moiety—the portion of the molecule responsible for clinical activity—in the title of the monograph emphasising that the moeity represents the strength of the product or preparation. We believe this will create consistency and clarity regarding names for products and preparations.
Manufacturers from any country, including India, should engage the US FDA early in the drug approval process with regard to naming of a drug product. The product should be named according to its active moiety as per this policy when determining its dosage. USP is currently reviewing FDA-approved drugs without a USP monograph. No name changes will be required for those products with a salt in the name and for which strength is expressed in terms of that salt. For products that have a salt in the name, but for which strength is expressed in terms of the active moiety, the USP monograph name will be determined on a case-by-case basis. Exceptions will be made to the policy (i.e., the salt remains in the name of drug) when the inclusion of the specific salt form of the active moiety in the name provides vital information from a clinical perspective or to maintain consistency with other dosage form monographs in a particular “monograph family.”
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