Small and Medium Pharma Manufacturers Association (SMPMA) has urged the Drugs Controller General of India (DCGI) to direct state drug authority to follow Drugs Consultative Committee's (DCC) guidelines for taking action on samples of drugs declared spurious or not of standard quality (NSQ) in the light of enhanced penalties under the Drugs and Cosmetics (Amendment) Act, 2008.

SMPMA also appealed to Union health and family welfare ministry to include specific definition of NSQ drugs in D&C Act, 1940 based on DCC guidelines. This will prevent misinterpretation of NSQ drugs as spurious and adulterated drugs and subsequently stop prosecution of licenced manufacturers whose drugs have been declared NSQ. As of now there is no definition of NSQ drugs in D&C Act.

Said Nipun Jain, chairman of SMPMA: “Though standards of drugs are prescribed under Section 16 r/w second schedule and Rule 124 to 126A of D&C Act, the term NSQ is not defined. Due to this, NSQ drugs are classified as adulterated or spurious drugs. As a result, genuine manufacturer who is not involved in manufacture of spurious or adulterated drugs, is exposed to harsh penalties and restrictions on bail. Therefore, it is necessary to include specific definition of 'NSQ' in D&C Act.”

He said manufacturers are not always responsible for NSQ drugs. Improper method of analysis or human error during analysis, lack of testing facilities such as equipment's, reagents, standards etc., testing performed by inexperienced personnel, government laboratories are not subjected to audit in the light of Schedule L-1 of the drugs & cosmetic act are also responsible for it. At times drugs despite having required quality parameters, requisite quantity of active ingredient, there are potency losses & decline in quality parameters such as disintegration, dissolution, related substances etc due to improper storage conditions at institutional level thereby stability issues arises, rendering the drug to be of not of standard quality.

In absence of directive to state FDA by DCGI, a number of licenced manufacturers whose drugs were found to be NSQ were prosecuted without proper evaluation of NSQ report in the light of DCC guidelines, on certain occasions as manufacturers of spurious drugs. Its high time, DCGI issues directive to state drug regulators to follow DCC guidelines to act against manufacturers for not ensuring drug quality.

The guidelines says spurious products are drug formulations manufactured concealing the true identity of the product and made to resemble another drug. It may or may not contain the active ingredients. Adulterated drugs are those drugs which are found to contain an adulterant/substituted product or contaminated with filth rendering it injurious to health.

The guidelines has categorized the drugs broadly under NSQ to include 'grossly sub-standard drugs' under category B and minor defects under category C. The grossly sub-standard drugs category includes following: active ingredient contents below 70 per cent for thermo labile products and below 5 per cent of the permitted limits for thermo stable products, tablets/capsules failing in disintegration tests wherever prescribed, liquid preparations showing presence of fungus, parental preparations failing in sterility, pyrogen/endotoxin test or undue toxicity, vaccines failing in potency, sterility, toxicity or moisture content.

Broken or chipped tablet, presence of spot/discolouration/uneven coating, cracking of emulsions are some of minor defects.

All the above may also be considered for inclusion under the category of NSQ, he added.

The guidelines proposed for setting up of a screening committee by state FDA to examine the investigation reports of the cases before launching prosecutions. Care should be taken that while violations with criminal intent or gross negligence leading to serious defects are dealt with heavy hand, the violations involving minor variations in quality by licensed manufacturers are resolved through administrative measures such as suspension of licence, it says.

Thus, for every report of NSQ drug, prosecution must not be the only criteria which is the current practice prevailing in the country, instead it should be actually investigated and reported giving due regards to the merits of the case where it is criminal intent or gross negligence. This act will safeguard the genuine manufacturers from not being harassed and will not have to face the agony of prosecution, said Jain.

Thus, for every report of NSQ drug, prosecution must not be the only criteria which is the current practice prevailing in the country, instead it should be actually investigated and reported giving due regards to the merits of the case where criminal intent or gross negligence has not been established at manufacturer's level. This act will safeguard the genuine manufacturers from not being harassed and will not have to face the agony of prosecution, said Jain.

Apart from these guidelines, test report issued by government analyst, complete testing protocol along with raw data and factual data and investigation report may be furnished to the manufacturer, which will enable him to exercise his legal right as given under the provisions of D&C Act. Further, investigation of the report of NSQ drug issued by the government analyst must also be carried out by the team of drugs inspector and representative of manufacturer. This will facilitate the manufacturer to safeguard himself under the provisions given in the Act.