RANBAXY LABORATORIES LIMITED

DESTRUCTION PROCEDURE FOR DATE

EXPIRED/DAMAGED/INSURANCE CLAIMS/QUALITY PROBLEM
STOCKS

Registration for BMW Generation, storage, handling

 As per Rule 8(4) of “ The Bio Medical (Wastes Management

and Handling) of Rules, 1998, “every occupier of an institution
generating, collecting, receiving, storing, transporting, treating,
disposing and/or handling bio-medical waste in any manner,
shall make an application in Form 1 to the prescribed authority
for grant of permission.

Receipt and Recording of LR

 LR copy along with product details as received from party is

handled over to store under acknowledgement.
 The stores enters LR in the Party Returned Goods Register and
gives a unique serial number-called as reference number.

Collection of Date Expired stocks

 Depending upon the date of LR and the estimated Transit Time

LR is handed over to Carting Agent under due
acknowledgement for collection of expired stocks.
 In case good are not received from any location within a
reasonable time say 15 days the carting agent takes
endorsement to this effect from transporters and returns the LR
to Office.
 Based on such endorsement party is informed either over
phone or thru a letter.

Receipt, Segregation and Checking of Date Expired Stocks

 Immediately on receipt of expired stocks in stores entry shall be
made in Inward Register.
 The cartons are marked with Unique serial number as
mentioned above (refer point no.2).
 The cartons shall be opened and checked if any saleable
stocks have been sent along long with expiries
 Saleable stocks found sent along with expiries shall be
separated and shifted to area designated for receipt and
processing of Sales Returned Goods. Details of such stocks as
regards to party, LR No. etc shall be provided to concerned
person.
 Suitable noting shall be made to this effect in the FRS register
 In case of any discrepancy a letter shall be immediately sent to
party with a copy to concerned filed managers. In case of large
discrepancy party shall be immediately informed over phone.
 The expired stocks so segregated shall be allotted a lot
number, which should be recorded on each carton either by a
permanent marker or a sticker be pasted.
 The entry shall be made in Lot Register.

 In case expiries of more than one division are sent by the party
under a single covering letter/consignment, photocopy of the
letter shall be taken and attached with claim processing papers
of other divisions. Reference on each such photocopy shall be
given of the claim where the original party letter is attached.
 Expired stocks shall be checked and processed as per laid
guidelines (Refer SOPs on Destruction of Date Expired Stocks)
and suitably marked with Lot Number.
 Pre-printed working sheets shall be used for processing
expiry claims.
 The working sheet is then sent to Computer Room and entry
made-ZBKD Report.
 The ZBKD Report is sent back to stores for cross checking and
confirmation to computer room.
 Each Carton shall also bear the reference of ZBKD report
number.
 After the ZBKD Report has been checked and verified
FRS/GCN is issued to party.
  Copy of FRS/GCN shall be attached along with the ZBKD
Report and attached/ pasted on the cartons before the auditors
are called.
 Utmost care shall be taken to ensure that a single ZBKD is
not processes more than once.
 The cfa would do value reconciliation of ZBKD and
FRS/GCN value which would be checked by auditors.
 The entire expired stocks shall be defaced using “INKING”
done thru a sprayer and using indelible ink only in the
presence of the Destruction Auditor/s.
 The ink shall be allowed to dry on stocks for at least two
hours.

Storage of Date Expired Stocks

 The expiries are to be stored in a separate room duly bifurcated

into three parts:
*Due for checking- Just received on which no action has been
taken
*Due for FRS/CNG-Process of checking has been completed
and ZBKD report
prepared but FRS not yet issued.
*Due for Destruction –FRS issued and goods shifted and are
due for destruction
 The expired stocks/storage location SL 002, SL 004 and SL
0010 stocks lying on shelves shall also be taken out by
transferring them to 005 location and then taking out thru
appropriate Movement Types like 551, 903 or 701 and later
shifted to Expired stocks due for Destruction Area in Expiry
Room
 All such stocks should be put in cartons and reference of PID
number mentioned on each of them
 In case a single PID is raised for large number of cases, the
numbering shall be in the form 1/5, 2/5, 3/5, 4/5 and 5/5 so as
to enable easy identification and traceability. Copy of the PID
shall be attached.
 All cartons bearing expired stocks( whether on account of shelf
expiries or expiries returned by trade) shall be labeled “ Expired
Stocks-Not for Sale” and only then shifted to designated area.
 The same applies even while sending the stocks for destruction
at Incinerator Facility. This is requirement of The Drugs Act.
 After the said exercise has been completed list of stocks to be
destroyed shall be prepared in the format as under:

SUMMARY OF STOCKS READY FOR DESTRUCTION

STATUS AS ON
Doc.Type Sr.No Sr.No Lot No.of
.- .-To No Carton
From s. s
ZBKD/FRS-Market Expiries
MOVT.551-Shelves
Expiry/Breakages/Quality
Issues/Transport Recoveries-
Breakages/Damages/Shoratges
(Less than Rs.1 k)
MOVT.903-Insurance Claims
Total weight

Audit of Date Expired Stock:

 Send request to RO/HO for appointment of Auditors

 Get the Audit Completed. The Attendance Sheet mentioning
the start and end time along with the names of the persons
present at the time of audit shall be prepared and kept in
records.
 Audit will take place in line with the Audit Steps that are issued
to the Auditors.
 The said attendance sheet may be subject to audit/cross
checking with Visitors Register maintained at security and
Attendance Register
 The auditor shall be requested to sign an interim report which
may be prepared by hand mentioning all vital details.
 The auditors shall do checking of expiries on sample basis and
the sampling size shall be as under:
 * For Movt Type 251/252, 551, 903 and 701-100%
* For Market Expiries 25-30%
 Auditor will endeavor to check Market Expiries on 100%
basis at least once in a year.
 The auditors shall carry out reconciliation of ZBKD Report with
the FRS issued to rule out issuance of FRS twice against a
single ZBKD Report. The details of said reconciliation shall be
mentioned in the audit report. However, in those cases where
GCN is issued directly from ZBKD (and FRS route is not
followed), to check and confirm that against single return, ZBKD
is not issued more at more than one occasion.
 In course of audit, entire expired stock, be it shelf expiry of
market returns, will be segregated into 3 categories, viz.,
bottles, tubes and strips. All the packing material, catch
cover/shrink packs to be removed and Indelible ink to be
splashed/sprayed on the entire expired stock.
 3 Categories of expired stock (bottles, tubes & strips) to be
packed separately in the specially designed bags. Also, packing
material removed to be packed, weighed and certified weight
recorded. Packing material along with the packing material to
be sent to Incinerator facility for ultimate destruction.
 All the Bags to be sealed by the destruction auditors, weight
taken and recorded. The seals duly signed by auditors and
cfa to be affixed on each bag.
 Destruction Auditors to specifically mention nos. of bags and
weight thereof in his destruction audit report and the fact that
the bags have been sealed in his presence.
 Each Location has to register with The State Pollution Control
Board by filing application under Rule 8(4) of “The Bio Medical
(Wastes Management and Handling) of Rules, 1998, Form –1.
Dispatch of Date Expired stocks to Incinerator facility

 After completion of audit, fix up with Incinerator Facility about

the dates for destruction.
 The segregation of expired stocks is the responsibility of Cfa
locations. The expired stocks shall be segregated into
categories after discussing with the Incinerator Facility.
 Locations should not attempt to destroy or otherwise initiate the
destruction process like emptying the bottles in sewerage and
defoiling the strips etc.
 In no case, repeat in no case shall the location violate the
applicable Environmental Laws.
 After getting confirmation from Facility please inform
RM/DM/Auditors/MRA/ Charanjeet Settia/Ashok Bhardwaj/Hira
Lal about the dates and site of destruction activity.
 Due intimation, in writing, shall be given to Regulatory bodies
wherever they are involved and it is mandatory on our part to
inform them. Proper acknowledgement should be taken under
sign and seal from concerned department and kept safely on
records.
 In case of destruction of Quality issue stocks, intimation
shall be given to department authorizing such destruction
with a copy to Corporate Finance.
 The stocks to be sent for destruction shall be packed in
colored bags as applicable- mostly black color. This is
required as per Laws. In case
 Physically move the stocks in a closed vehicle thru a reliable
carrier. Cfa representative shall accompany the
consignment
 At the time of shifting expired stock from CFA location to
Incinerator Facility, each bag must be distinctly numbered.
 For example if total 20 bags are being shifted the numbering
may be done as DELHI/1/20, DELHI/2/20 etc.
 Impeccable dispatch documents shall accompany the
consignments including Permits wherever required.
 The seals on the bags would be checked at the time of
receipt at incinerator facility and auditors would have to
certify the same.

Destruction of Date Expired Stocks at Incinerator Facility

 The capacity of the Incinerator Facility shall be assessed for

daily destruction and accordingly expiries be sent there for
destruction.
 The Incineration job shall preferably be completed on a
single/same day and spill over of destruction process to next
day shall be avoided.
 The destruction shall be done only when all of the followings
parties are present for destruction at the facility:

*Cfa Owner/Cfa Manager or any person deputed by Cfa- Must

Every Time
*Auditors-Must Every Time
*MRA/Sr. Manager A& C or from RO their representative – On
a random basis more from the perspective of process
compliance but to ensure that at least one destruction is
witnessed in a year at all the locations of their jurisdiction.
*Either of Ashok Bhardwaj/Charanjeet Settia -
Optional and they should act as Surprise Auditors.
*Surveyors whenever required –as there could be destruction of
Insurance Claim
related stocks – this has since been clarified by the Insurance
Cell that destruction of damaged stock could be incinerated
along with the destroyed stock subject to inking of the damaged
stock at the time of survey. If, however, surveyor wishes to
witness destruction of damaged stock, CFA should facilitate the
same.
*Authorized personnel from Incinerator Facility-Must Every
Time
 The Incinerator Facility sure must be maintaining Entry
Register/Visitors Register at their facility, and if not, we shall
get this implemented with immediate effect.
 The destruction shall be done strictly as per the Unique
Identification number allotted by Cfa.
 All persons attending the Destruction Process shall sign the
Entry Register.
 All persons shall remain present till the very end of the
destruction process.

 At the end of destruction Process All present would certify that

Expired stocks have been destroyed following the applicable
environmental laws and that they are satisfied with the entire
destruction process.
 In case any of the participants in the destruction process
has a differing view the same shall be recorded and
highlighted to RO/HO.
 In the event of destruction not being completed same day
Interim Report shall be prepared indicating the amount of
expiries destroyed and balance number of cartons remaining to
be destroyed along with Unique Identification Serial Number.
 Once a bag is taken up for destruction it should be completely
destroyed and not left half way processed.
 The Incinerator Facility shall provide us a separate lockable
room at its site to store left over expired stocks.
 The inventory of left over stocks shall be taken before shifting to
this room and recorded.
 The Room shall be locked and a tissue paper slip duly signed
by Ranbaxy and Incinerator facility representatives shall be
pasted on locks.
 All Windows/opening to the room should be suitably sealed.
 If possible Ranbaxy Security Guard may be placed on night
duty as is being done at few locations.
 The destruction process next day shall not commence until the
left over stocks inventory has been taken in the presence of all
who need to be present and tallied with closing Inventory.
 After the completion of destruction process a Report shall be
prepared mentioning number of bags destroyed, weight
involved the duration of the destruction process, names of all
 present and method of destruction followed for the said process
especially as regards to disposal of packing materials like
bottles, cartons, labels, shippers etc.
 It is also to be mentioned that materials have been destroyed
following company’s policies and Environmental laws for which
knowledge of applicable Environmental Laws would become
essential. Copy of Guidelines attached.
 The Method of destruction of Date Expired stocks is
Incinerator/Secured Landfills. No other method including ETP
(Effluent treatment plant) is to be used.
 The use of Autoclaving should be done wherever required and
stocks disposed off after that only.
 Each location shall go thru The Bio Medical Waste
(Management and Handling) Rules, 1998, and give training to
all concerned.
 The report prepared shall be signed by all and circulated within
2 days of the conclusion of the job
 The Cfa, auditors as well as Facility shall issue Certificate
mentioning complete details of destruction, the process and the
method of destruction followed.
 All documents, as mentioned above, shall be attached with the
bill before the same could be processed for payment to
Incinerator Facility or auditors
 All documents shall be well preserved for audit purpose.

Safety Measures at the time of Destruction Procedure

  The Cfa and other personnel from Ranbaxy shall take turn by
rotation. This shall be compulsorily followed to avoid
excessive exposure to risk to a single individual.
 The persons attending the destruction process shall be
subjected to Immunization as prescribed. They shall be
positively immunized for Hepatitis A, B C HIV, DTT, ATS etc
 The presence of Cfa personnel and auditors is a must
throughout the entire destruction process.
 Persons presiding over Destruction Process shall be subjected
to Half Yearly Routine Medical examination focusing mainly on
Chest/lung infections and X-ray.
 All Cfas shall ascertain cost of such immunization and get the
same done for concerned persons after taking approval from
their respective regional offices.
 Safety Precautions: Persons with weak immune system,
diabetics, injured/wounded, with open cuts/wounds/injury,
suffering for any viral infection etc. should not be allowed to be
present at destruction.
 All who are present shall use surgical /air filter masks, caps,
gloves at the time of destruction.
 The destruction process shall be carried only during the day
time.
 The date fixed for destroying our Waste shall be such that, as
far as possible, it does not coincide with destruction of Category
1 waste-human, tissues, organs, body parts.

Training of staff on Bio-Medical Waste Management and

Handling

 Training of Stores and other concerned staff on Handling and

Destruction of Expired stocks shall be done in accordance with
applicable requirements of Law.
 Training of staff shall focus on safety and related health issues
arising out of Destruction of Expiries.
 Training shall include the auditors and it would be better to
involve incinerator facility personnel also as they can share
requirements prescribed by law and their work experience.
 The Training Records shall be well preserved and
 Activities consequent to Training like Feedback forms and
Evaluation of its effectiveness shall be done for each trainee
and records maintained.