Pharma trade & industry has grown leaps and bounds from a mere around Rs 5000 crores to more than Rs one lakh crores and from an importing country to a leading exporter. The Drugs and Cosmetics Act 1940 and Rules 1945 regulates the import, manufacture, distribution and sale of drugs [D&C Act]. The Drugs (Prices Control) Order 2013 regulates the prices of formulations moving in the market and its availability to the needy public.

The D&C Act has gone through a number of amendments periodically in tune with international standards. However the practice of pharmacy and law requires further fine-tuning to ensure zero defects in practice and in enforcement. Some of the steps required in this regard is highlighted here.

  Pharma trade includes all segments of trade starting from the despatch of drugs from factory upto the delivery to consumer i. e the retail outlet. The drugs released from factory outlet shall confirm to the specifications laid down in I. P or to the requirements of the importing country as per the standards of USFDA/MHRA. However the quality has to be maintained till it reaches the consumer through various channels of distribution and this depends on the following factors:

• Storage condition at the wholesale/retail outlet which includes space, storage environment and the competency of the persons handling it
• Method of transport which covers the transport time and storage condition during transport
• Handling procedures during different stages to prevent pilferage, substitution with counterfeit/spurious drugs and mix-up
• Effective enforcement at all the above points
• All the above four factors can be broadly termed as Good Distribution Practices and what we see today is that all the above require improvement in the following aspects
• Initially the Act was silent on the minimum area for a diligence, but now it is specified. What we see in practice is that everybody tries to comply with the minimum requirement to "get" a licence without considering his estimated volume of business, which may require a larger space. As the business gets going, the dealer tries to accommodate within the limited space resulting in the inability to enforce First-in –First out. This leads to accumulation of expiry drugs and lack of info on the various drugs stocked. In some places either the dealer or the Inspector may not be able to cross & reach the drugs stored at the other end or near the wall. The dealers do not arrange the drugs and store it in a scientific manner with rack information system with adequate space between any two drugs leading to wastage /loss due to expiry, overstock and with consequent financial implications This applies to both retail and wholesale, more so for a wholesaler . Hence, it is in the interest of a dealer to have his own drugs information system and rack management system and to study the drug movement pattern for having a minimum stock level & reordering pattern, which will also help him in payment schedule. The Dealers have to be educated by the Inspecting officers on better inventory management and trade practices. Some dealers and government institution like TNMSC are doing it.

Another grey area is the storage condition. The Act specifies that the drugs shall be stored as per the storage condition prescribed in the Act and as per the labelling requirements. Most of the dealers provide only a refrigerator to comply with provision without reference to its size in relation to the drugs requiring cold storage. Cases have been observed where huge stocks of insulin and other drugs have been stored in open rooms due to shortage of space in fridge leading to precious wastage of drugs, if noticed and seized, or loss of potency in case it is not detected by the authorities. In addition now-a-days even some tablet items require cold storage, which is not known to many dealers. Here also one requires the application of mind on both sides to ensure quality of drugs with an additional responsibility on the inspecting officer to convince on the necessity. Some cases require cold rooms also, though not specifically mentioned in the Act, with relevant monitoring systems. Considering these facts, licence is issued in Tamil Nadu if the premises is air-conditioned in addition to refrigerator/cold room as may be required. This step in addition, helps in control of dust particles in the premises and on the drugs stored. Hence, it is the responsibility of the licencee to provide adequate storage facilities to maintain the quality of the drugs stored in his premises.

Competency of the person handling the above operations plays a vital role in maintaining quality of drugs supplied. The Act now specifies the qualification for competent person in wholesale and requires a registered pharmacist in retail.

The dealers may be well advised on the importance of the service of the technical staff required as per relevant rules, instead of considering it as a liability and having them for record purposes, which will definitely lead them to legal complications at some stage.  

• Transport of drugs require compliance to the prescribed storage conditions at the time of transport including at the transit points. It is observed that at present focus is mainly on storage condition at the sales points instead of at the transport/transit points also. The quality of the drug will deteriorate, if exposed to a higher temperature than indicated for a considerable period of time and it progresses proportionately. Here, in my opinion, the manufacturers have an important role to play and they can see to it that it is transported as required at all their dealing points. The enforcement authorities can monitor the movement of select group of drugs from the transport angle, which plays an important role in maintaining the quality of drugs. In my view, the Act can have specific provisions relating to storage condition during transport of drugs.
• Handling procedures for drugs requires a focussed training at all levels of distribution chain. The Drugs & Cosmetics Rules specifies the conditions of sale and requires that sale shall be under a bill as specified in the rules and under the supervision of a competent person /registered pharmacist. By this provision, what we see in practice is that:
• bills are raised, without actually receiving the stock to create records of sale, (which will delay the investigations of spurious drugs)
• bills are raised in the name of fictitious firms/persons, but drug diverted to other channels
• bills are raised in the name of existing firms based on the details in database of the seller, but the drugs supplied elsewhere.

These activities usually happen in cases involving movement of spurious drugs and in cases of sale to unlicensed dealers. The above practice can be regulated by making it compulsory that seller has to ensure that the drugs are delivered with an acknowledgement from the purchaser or by making payments through banking channels. This step may help in regulating the transactions. It is also in the interest of the trade.

Another grey area in wholesale to retail sale is the inability to supply the specific drug with correct batch number.  Based on orders from retail outlets, the wholesaler identifies and keeps the drugs isolated for each retailer and the delivery boys take it for delivery to retail point. At this point care is not taken to pack the drugs separately for each shop and consequently at the time of delivery though the drug may be same but of different batch number. The purchasers do not verify it for batch accuracy, but only for quantity. Using this lacunae, some delivery boys mix up or substitute spurious drugs received from clandestine sources. Dealers may develop suitable logistic system for effective drug delivery with zero defects taking adequate care to prevent mix-ups/substitution and transit loss and with compliance to storage requirements.

It is suggested that the dealers may be educated on their role in delivering standard quality drugs with necessary precautionary steps and to have a better drug delivery model and logistics to ensure that no mix up of any sort happens. The wholesaler may have a system of verifying the details of the name, address and licence details of purchaser periodically including correctness of address.

 The retail dealer must ensure that the drugs are purchased under a valid bill from a licensed dealer and verify the stocks received for its correctness in all aspects before selling it. The sale by a retailer shall be under a bill for all drugs under a valid prescription and with name and address of prescriber and the patient. But in practice, what we see is that drugs are sold without prescription and even in case with a prescription the name and address of prescriber and patient are not recorded. This practice will make monitoring difficult in case of reporting of ADR of a drug. It is ideal to have a typed/printout of a prescription for clarity in dispensing and to eliminate dispensing errors in the interest of the patient. The attempt of FDA, Maharastra in this regard can be tried by others.

 The Act requires specific provisions relating to Internet Pharmacy, as a number of misuses have come up of late and it is required urgently.

• Better Enforcement is the best way to ensure quality of drugs moving in the market and to ensure that no spurious or substandard drugs is moving in the market. This requires better co-ordination between states and between state and CDSCO through nodal officers of the intelligence wing. It has to be on proactive mode with speed in initiating action and its follow up with accuracy and better coordination in public interest. Detection of spurious drugs requires sampling drugs in scientific manner with relevant intelligence inputs based on market movements /price fluctuation and other factors.
• For better enforcement, the amendments of the Act and rule is urgently needed on the above aspects in addition to the following points.

There is no specific provision on recall and destruction of expired drugs, as the present provision specifies that drugs after their date of expiry shall be stocked separately with a relevant label indicating the same. There is no specific provision mandating the dealers/manufacturers on the steps to be taken by them for an effective recall and destruction of drugs after their date of expiry. An attempt was made some time back to specify the provisions by constituting a DCC sub committee, based on the request of Tamil Nadu after an incidence of recycling of expired drugs. Act may be amended urgently specifying relevant provision for recall /disposal of expired drugs.   

  To monitor movement of drugs and to prevent entry of spurious drugs in the market, Tracking System with suitable bar coding may be ensured. This will help in tracking movement of drugs from manufacturers level to the consumer level enabling consumer to have the knowledge of the drug he is consuming and will ensure his confidence level. It is suggested that some incentive/subsidy may be considered to overcome the inhibition due to cost factor and to encourage it.

Another suggestion which will have implication in reducing the cost of newer molecule in the market is to make it mandatory for the foreign manufacturer to manufacture it in India instead of importing the same. This can be achieved since there are many US FDA/MHRA approved units in India.