Recently, there have been many complains against drug firms by not only the USFDA but also DCA in India, which has also pointed out a lot of discrepancies particularly in packing of drug products. It is observed that though many firms are following strict standards in manufacturing of the drug products, they are not showing the same keenness in packing the products. Because of this, recently, a leading pharmaceutical manufacturer had to face the ire of US FDA and had to pay huge amounts of money as penalty for its failure in ensuring safe packing. “Pharma firms need to be vigilant and should not give the least chance for the inspection authorities to point out any lacunae. It is the responsibility of the firms to take care of its products till it reaches the end user,” says an industry expert.
The importance of packaging
The role of packing is highly significant particularly in the pharma industry as it ensures the safety and gives long shelf life by protecting the product until its expiry. The packing material used should ensure long-term safety of the product. The materials used should not only protect the product from physical damage but also ensure that the product should not deteriorate chemically. In fact the packing will have to ensure that medicinal product doesn’t get impacted from mechanical and climatic hazards. Packing methods and the materials used should protect medicines from micro-organisms and also should be child resistant and tamper proof.
Expectations from packaging
Though pharma manufacturing and packing are two different entities, both should go hand in hand to ensure the safety, quality and efficacy of the product. Having said this, the pharma industry has a lot of expectations from the packing industry. In fact, the pharma industry wants the packing industry to customize its packing methods to suit the product stability.
Primarily the pharma firms expect the packing industry to ensure high standards of packing quality by adopting good design relevant to the needs of product and manufacturing and distribution system (of both customer & supplier).
The packing industry must adhere to all the stability parameters that are essential for protecting the products from moisture, gas, light and temperature. Protection from microbiological integrity and pH stability are other important parameters that the firms need to keep in mind while packing sensitive medicines.
The packing industry must also ensure the compatibility of packaging material particularly while doing packing of preservatives and volatile actives. To avoid leaching from packaging, the packing firms must use proper stabilizers, plasticizers, additives and anti-oxidants.
In the packing lines, the packing department should also ensure proper machine suitability. It is maintain line speed, tolerance and reliability while packing of medicinal products. It should also ensure that every package is having exact fill weight, labeling and storage. “Dr. Reddy’s has made its manufacturing and packing of medicinal products automated. We produce more than nine billion pills every year. We have a highly integrated manufacturing facility in Hyderabad. Our facility is one of the pioneers in adopting automation right from the entry level to the final packaging. We have installed highly sophisticated machinery at our processing units and packing units and it is also manually verified frequently to ensure 100 per cent safety of the products,” said Abhijit Mukherjee Chief Operating Officer, Dr Reddy’s labs, while explaining about automatic systems used in packaging and manufacturing of pharmaceutical products at one of its units in Hyderabad.
Recent regulations in packaging
The Indian government has brought in various regulations in packing of pharmaceutical products.
The implementation of bar-coding is one more step to ensure the quality of Indian products.
The trace and track technology which was adopted by the government to address the issues and apprehensions about the export of spurious drugs from India, was made compulsory for tertiary level packaging from October 1, 2012 and for secondary level packaging from January 1 last year.
The barcode packaging regulations at the primary level was expected to take effect from July 1, 2014 but recently the commerce ministry has deferred it heeding to the request of exporters. A barcode helps in tracking and tracing the origin of drugs which in turn helps in minimizing chances of genuine drugs being considered spurious, sub-standard or counterfeit.
However, the exporters have pointed out that the primary level bar-coding is practically impossible, especially for small products like injections, apart from causing heavy burden on the exporters who are already hit by increasing registration costs and other non-tariff trade barriers by the developed markets. They also claim that no other country has made it compulsory for exports.
US FDA proposal for labeling of generic drugs
In November last year, the FDA had proposed a rule that would allow generic drug makers to update product labeling safety information using the same process as brand drug manufacturers. Under the proposed rule, generic manufacturers could unilaterally change their safety-related product labeling through the "changes being effected" (CBE-0) supplement process.
Those changes would take effect concurrently with the companies' notification of the FDA and the branded drug manufacturer. No prior approval would be required. The current regulatory system permits generic manufacturers to use CBE-0 only to update their labels in conformance with the branded drug label.
“It is easy to see why the agency would propose such a change. The realities of the prescription drug landscape -- more than 80 per cent of the drugs dispensed in the US today are generic -- have altered the risk-benefit balance between clarity, consistency, and speedier access to safety information. The FDA has long held that, to ensure patient safety, the labeling of generic drugs must be identical to that of the listed drug. This is mainly because a generic drug's approval is based on safety and efficacy studies of the reference-listed drug. Now, generic drugs are prescribed as alternatives to the branded product, often under the assumption that they are truly identical. But the criteria for establishing bioequivalence are broad. Some physicians' organizations have stated that certain methods for determining bioequivalence for some specific drug dosage forms may be flawed,” points out Bikash Chatterjee President & CTO, Pharmatech Associates .
There are many questions about the validity of the proposed rule change, including whether the FDA has the authority to implement it. And the confusion resulting from generic and brand drug manufacturers having different labeling could be a nightmare.
The FDA is proposing to address the issue of multiple versions of safety labeling by creating a website listing all the pending CBE-0 supplements for safety-related labeling changes. I am not sure how I feel about the government creating a healthcare website to solve the problem. The consequences of this proposed rule change would be profound for consumers and manufacturers alike, opines Chatterjee.